79 Regulatory Writing jobs in Singapore
Accurate Clinical Documentation Specialist
Posted today
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Job Description
Medical Transcriptionist
About the Role
We are seeking a skilled Medical Transcriptionist to join our team. In this role, you will be responsible for transcribing and interpreting recorded dictations from doctors.
Your primary focus will be on ensuring accuracy, completeness, and consistency in your work.
You will also identify inconsistencies, errors, and missing information within reports that could compromise patient care.
Additionally, you will submit health records to physicians for approval and follow confidentiality guidelines and legal documentation requirements.
In terms of administrative tasks, you will file and upload transcribed reports as needed.
Please note that this is a full-time position with a 5.5-day workweek (Monday to Friday; Half Saturday) located in Orchard.
Requirements- At least GCE 'N' or 'O' Levels, Professional Certificate/NiTEC, Diploma/Advanced/Higher/Graduate Diploma in any field
- Related working experience in healthcare and understanding of medical terminology/abbreviations/jargon will be an added advantage
- Strong computer/typing skills. Proficient in MS Office
- Meticulous, eye for details, precise, organized, and efficient
- Good communication and interpersonal skills
- Effective team player and able to work in a fast-paced environment
- 5.5 days work week
- Located in Orchard
- Cinematics
- Typing
- Sponsorship
- AED
- Quality Improvement
- Healthcare
- Medical Terminology
- Copy typing
- Motion Capture
- Casting
- Characters
- Speech Recognition
- Answering phones
- Attention to Detail
- Transportation
- Storytelling
- Transcription
- Audio typing
- Personal Development
Regulatory Affairs
Posted today
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Job Description
Principal Task: The successful candidate will first and foremost be responsible for regulatory affairs and product registrations for all SciMed products. The candidate will be the focal point of contact for advice on regulatory guidelines and activities. Besides regulatory affairs, the candidate will also support the Management Representative in ensuring an effective Quality Management System (QMS) and local implementation of PHC's compliance policies and ensure full adherence where necessary.
1. Regulatory Affairs
- Understand relevant regulatory regulations, policies & procedures behind the company's business activities and products
- Ensure product and company's compliance with regulations for maintenance of approvals
- Maintain ISO and GDPMDS records, and work closely with the ISO/GDPMDS team to provide timely updates on company's regulatory and licensing matters
- Preparation and submission of regulatory applications, including creating and maintaining templates and ensuring completion of submissions
- Advise management on regulatory processes, compliance and updates to policies
- Responsible for the maintenance of regulatory documentation databases
- Develop and maintain communication with regulatory agencies regarding submission strategies, compliancetest requirements, potential regulatory pathways, or clarification, and follow-up on submissions and reviews quality management systemo new product(s) launch in local and/or regional markets
- Main contact point for various regulatory-related internal inquiries regarding logistics, pre/post-marketing events in addressing customers' requirements.
- Support the country managers in medical device regulations or other regulations for regional countries
- Liaise with related departments in the PHC Group
2. Quality Management System
- Support the Management Representative in the company quality management system
- Maintain and update the document control system to ensure all quality-related documents are easily accessible, properly categorized, and up to date.
- Oversee the implementation and maintenance of Quality Management Systems (QMS) in accordance with ISO9001, GDPMDS and other relevant standards.
- Review and update ISO 9001 & GDPMDS documents when necessary and maintain records.
- Review and ensure all documents, including SOPs, work instructions, manuals, and forms, meet regulatory and company standards.
- Handle quality related matters such as non-conformances, customer complaints, change notification.
- Handle customer or supplier related enquiries, questionnaire and etc.
- Prepare for internal and external audits and ensure successful outcomes, tackle audit findings and recommendations in a timely manner
- Follow-up and verify corrective/preventive action (CAPA) effectiveness.
- Provide ISO 9001 and GDPMDS orientation to new employees
3. Compliance
- Coordinate, schedule and conduct required compliance orientation and training for employees
- Responsible to ensure compliance to regulations related to export controls and maintain records
- Provide support to employees on regulatory requirement and compliance procedures.
- Serve as a BizSafe member by overseeing and coordinating the preparation, management, and maintenance of all risk management and related documentation. Ensure all required documents are completed, up-to-date, and in compliance with BizSafe standards and regulations.
REQUIREMENTS
Candidates should bring with them
- A Degree in Life Sciences, Biomedical or any other related discipline.
- Minimum 2 years' experience in performing a similar job scope.
- Relevant experience in regulatory affairs will be advantageous
- Good knowledge and application of Microsoft 365.
- Able to work under a matrix reporting structure.
- Good organizational and time management skills.
- A strong database experience (Access, Excel) to set up functions, enter data or process information.
- Excellent interpersonal, presentation and verbal/written communications skills.
- Meticulous, able to work independently and timely in meeting deadlines.
- Integrity with a history of ethical decision-making is essential
- Sound knowledge of the regulatory requirements and legal framework for products and industry trends in the Asian Region.
- Knowledge in GDPMD, ISO9001, IVDR preferred.
- Familiarity with Health Science Authority's regulatory on medical devices, product registration, field safety correction and licensing requirements.
Licensing
CAPA
Quality Management
Quality Management Systems
Regulatory Affairs
ISO
Risk Management
Compliance
Medical Devices
Audits
Regulatory Requirements
Life Sciences
Audit
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
Job Title: Regulatory Affairs Specialist
Location: Singapore
About Us:
The company is a global pharmaceutical company with significant presence in Asia, with operations in multiple countries.
Key Responsibilities:
Formulation of pharmaceutical strategies in collaboration with other teams and departments
Monitoring and tracking of pharmaceutical operations at each local company
Qualifications:
2-3+ years of experience in pharmaceutical business
Proactive, high level of initiative, communication/negotiation skills, logical thinking
Interested applicant, please click APPLY NOW
Do note that we will only be in touch if your application is shortlisted.
Peh Yong Sin
JAC Recruitment Pte Ltd
EA License Number: 90C3026
EA Personnel: R2197665
#LI-JACSG
#countrysingapore
#J-18808-LjbffrRegulatory Affairs Specialist
Posted 1 day ago
Job Viewed
Job Description
About Soleil Collective
Backed by Gauge Capital, Soleil Collective is building a portfolio of leading high-growth brands specializing in sunless tan, suncare, and bodycare products. Soleil accelerates growth and improves profitability with sales, marketing, operations, and strategic management expertise. We have completed two acquisitions to date: Loving Tan and Coco & Eve.
Loving Tan is the category leader in prestige tanning, delivering the most natural-looking tan. Proudly made on Australia’s Gold Coast, the professional quality, natural olive color, and flawless application are beloved by A-listers, creators, and beauty lovers alike. Coco & Eve’s story starts in Bali, among volcanic beaches and lush rainforests. The brand offers sun-kissed, skin-loving tan products and deliciously scented, efficacious haircare formulated with tropical Balinese ingredients.
Responsibilities
Product Compliance
- Work with Brand and Product Development to ensure compliance of all new and existing products with global legislative requirements (FDA, EC, HSA, etc.).
- Complete registration of all new products/categories not covered by external regulatory partners.
- Liaise with regulatory agencies and manufacturers to resolve compliance issues and suggest corrective measures.
- Assist in substantiating product claims through research and provide evidence to Marketing and Brand teams.
- Support Product teams in quality-related matters, ensuring adherence to international standards and overall product compliance.
Business Development Compliance
- Provide guidance on regulatory requirements for entering new markets and channels.
- Evaluate compliance submissions from new retailers and act as the main contact until registration is complete.
Vendor Management
- Support the Operations Director in screening new suppliers and conducting due diligence.
- Define minimum factory compliance requirements (CSR), ensure conformity, and lead sustainability improvement initiatives.
- Coordinate with Legal and Quality teams to communicate requirements to trading partners and manufacturers.
- Collaborate with regulatory partners to develop a global compliance matrix for Soleil Collective’s current and future product categories and markets.
Regulatory Affairs – Singapore
Posted 3 days ago
Job Viewed
Job Description
What to Expect
- Establish and manage regulatory submission timelinesfor both new and existing products across key global markets
- Prepare and file global medical device applications and amendments, ensuring timely market access.
- Engage with regulatory authorities and distribution partnersto support product registrations
- Author and maintain EU MDR-compliant technical documentation, including notifications of change, and lead all EU regulatory initiatives.
- Conduct global regulatory impact assessmentsfor product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
- Act as the regulatory representative on cross-functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
- Interpret and apply international regulations, standards, and directivesto ensure ongoing global compliance.
- Review and approve product labelingto ensure compliance with global regulatory requirements.
- Support and participate in inspections and auditsconducted by global regulatory authorities.
Requirements
- Minimum 5 years of Experience
- Fluent English
If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 000 or email
Tagged as: Regulatory Affair
#J-18808-LjbffrRegulatory Affairs Executive
Posted 3 days ago
Job Viewed
Job Description
- Support product registration activities, including the preparation of registration dossiers, performance evaluation study design, and coordination with CROs (Clinical Research Organizations).
- Act as the subject matter expert on medical device regulatory requirements, with a particular focus on FDA regulations. Stay current with relevant laws and ensure internal practices remain compliant.
- Interface with global regulatory authorities such as the FDA, Health Sciences Authority (HSA), and Medical Device Authority (MDA). Track submission progress and manage responses to queries or objections during the review process.
- Participate in clinical verification, product testing, data collection, and ongoing tracking activities to support both regulatory submissions and product performance validation.
- Prepare and submit scientific and technical documentation for special projects or novel product classifications.
- Foster professional relationships with regulatory bodies, third-party experts, and key opinion leaders to strengthen regulatory pathways and advocacy.
- Collaborate cross-functionally with internal teams (e.g., R&D, Clinical, Quality Assurance) to align regulatory strategy with overall business goals.
- Undertake any additional regulatory tasks or projects as assigned by the management team.
- A Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related discipline.
- Minimum 2 years of hands-on experience working with the FDA on medical device registration, submissions (e.g., 510(k), IDE), or related regulatory pathways.
- Demonstrated skills in project management, planning, execution, and timely communication. Strong presentation and technical writing abilities are essential.
- Enthusiastic, proactive, and professional work ethic with a high level of accountability. Strong interpersonal skills and the ability to collaborate across teams.
- Detail-oriented with a high degree of responsibility. Able to handle regulatory pressure and manage tight timelines effectively.
- Willing and able to travel to the United States for one month every six months as part of regulatory project and stakeholder engagement needs.
Director Regulatory Affairs
Posted 3 days ago
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Job Description
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To combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has division level influence and responsibility and is generally considered a key opinion leader and an expert resource both within Abbott and externally. The individual will be actively called upon to influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information.
Main Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Strategic Planning
- Identify need for new regulatory policies, processes and SOPs and approve them.
- Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture.
- Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
- Develop global regulatory strategies and update based upon regulatory changes.
- Anticipate emerging issues and develop solutions to them.
- Develop solutions to address issues with other members of management and stakeholders.
- Develop corporate positions on regulatory risk-benefit.
- Create and develop product positioning strategies based upon regulatory requirements.
- Integrate regulatory considerations into the corporation’s global product entry and exit strategy.
- Provide guidance for resource and development planning.
- Participate in applicable trade association/industry working groups to influence policy/rulemaking in alignment with business strategies Pre-market.
- Communicate application progress to internal stakeholders.
- Negotiate with regulatory authorities during the development and review process to ensure submission approval.
- Provide strategic input and technical guidance on regulatory requirements to development teams.
- Ensure pre-approval compliance activities are completed.
- Formulate company procedures to respond to regulatory authority queries postmarked.
- Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests.
- Ensure a system is in place to manage access to information requests.
- Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance.
- Identify and present option for risk mitigation to decision makers.
- Ensure adverse events are reported to regulatory agencies and internal stakeholders.
- Manage processes involved with maintaining annual licenses, registrations, listings and patent information.
- Ensure compliance with product post-marketing approval requirements.
- Review and approve advertising and promotional items to ensure regulatory compliance.
- Country-specific regulatory support, including the SEA market.
- Scope is division-wide regulatory direction for product development and support to develop most rapid successful strategy for approval to market products to meet business objectives; administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions; attract and develop superior regulatory professionals and regulatory competencies.
- Must assure that all deadlines are met and provide effective leadership without direct authority.
- Individual is recognized as a key opinion leader and resource in regulatory affairs.
- Develops, communicates, and builds consensus for operating goals that are in alignment with the division and corporation
- Provides leadership by communicating and providing guidance towards achieving department, division and/or corporate objectives
- Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units
- May lead a project team or initiative within department or cross-functions/divisions
- Provides technical leadership to business units
- Exercises judgment independently
- Leads assigned departments by developing, communicating, and building consensus for goals and programs that support division, business unit and company objectives
- May participate / lead external industry working groups to influence advocacy in alignment with business strategies
- Creates mid- to long-range plans to carry out objectives established by top management
- Develops and calculates a budget for one or more departments to meet organizational goals
- Forecasts future departmental or group needs including human and material resources and capital expenditures
- Determines and establishes organizational structure and supervisory relationships subject to top management approval
- Assignments are expressed in the form of objectives
- Work is performed without appreciable direction
- Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.
- Consequences of erroneous decisions or recommendations would normally include delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity
- Bachelor's degree (or equivalent); bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 12+ years’ experience in a regulated industry (e.g., medical products, nutritional). 12+ years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
- Regulatory history, guidelines, policies, standards, practices, requirements and precedents
- Regulatory agency structure, processes and key personnel
- Principles and requirements of applicable product laws
- Submission/registration types and requirements
- GxPs (GCPs, GLPs, GMPs)
- Principles and requirements of promotion, advertising and labeling
- International treaties and regional, national, local and territorial trade requirements, agreements and considerations
- Domestic and international regulatory guidelines, policies and regulations
- Ethical guidelines of the regulatory profession, clinical research and regulatory process.
- Monitor costs of projects and of human and material resources within a department or unit
- Monitor company-wide indicators such as market share and profitability
- Develop least cost, least time means to provide optimal regulatory support for new products
- Monitor external environment in area of technical or professional responsibility
- Direct and manage the preparation of technical strategic regulatory documentation for agency submission
- Communicate effectively verbally and in writing
- Communicate with diverse audiences and personnel
- Work with cross-functional teams
- Work with people from various disciplines and cultures
- Write and edit technical documents
- Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies
- Negotiate internally and externally with regulatory agencies and participate in political lobbying
- Plan and conduct meetings
- Demonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks
- Effectively negotiate regulatory agreements with global regulatory agencies
- Negotiate regulatory and scientific issues with management
- Adjust presentation style and content to suit the audience
- Seniority level Director
- Employment type Full-time
- Job function Legal
- Industries Hospitals and Health Care
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Director P&B Regulatory Affairs Asia Pacific Director of Regulatory Affairs and Quality Senior Associate Director, Health, Public Policy and Communications JAPAC Strategic Planning & Operations Sr. Manager Regulatory Affairs Senior Regulatory Affairs Manager- Singapore - Remote Manager, Regulatory Affairs APAC (Excl CN & JP)We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Regulatory Affairs Specialist
Posted 11 days ago
Job Viewed
Job Description
Job title: Regulatory Affairs Specialist
Reference ID: 36639
Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring activities across local affiliates.
You will be reporting to the Regulatory Affairs Department in Japan.
【 Responsibilities 】
‐ Handle mainly regulatory operations tasks
- Report directly to the Regulatory Affairs Department in Japan
- Coordinate regulatory submissions (new and variation) across Asia/ASEAN
- Manage regulatory documents and ensure timely submissions
- Develop regulatory strategies with cross-functional teams
- Track and monitor local affiliate regulatory activities
- Identify and resolve regulatory issues proactively
【 What you will receive 】
- AWS
- Variable Bonus (Depends on Company and Individual performance)
- Annual Leave 14 days
- Medical Leave
- Medical Benefits
- Flexible Benefits (S$1500/year)
- WFH: Once a week to be at the Office, other days WFH
【Requirements & Preferences】
(Must)
- Diploma in any discipline.
- Minimum 2 years of experience in Regulatory Affairs within Singapore's pharmaceutical industry.
- Proficiency in both written and spoken English is required to liaise with counterparts and handle documentation.
- Proactive, self-motivated, and able to take initiative with high energy levels.
(Advantageous)
- Strong communication and negotiation skills.
- Logical thinking and sound problem-solving capabilities.
- Ability to adapt well to changes and work effectively under pressure.
---
We regret that only shortlisted candidates will be notified.
Registration No.: R24122864 (Cathy Chau )
Recruitment Licence: 12C5051
REGULATORY AFFAIRS MANAGER
Posted 14 days ago
Job Viewed
Job Description
Gene Solutions, a pioneer, rapidly growing and well-funded biotechnology company with cell-free DNA platform focusing on women’s health and oncology. We aim to transform the standard of healthcare in developing countries by making breakthrough genetic tests affordable and accessible to millions of people.
We have multiple openings for business development managers who will be working in South East Asian countries to serve our exponential growth.
Job Summary:
Lead and coordinate registration of international biotech certifications (CAP, FDA, HSA, NMPA, etc.) across APAC. Manage and collaborate with across relevant team/member to ensure timely and compliant registration.
Key Responsibilities:
· Develop and execute registration strategies for CAP, FDA, HSA, NMPA, and other international certifications within the APAC region.
· Manage end-to-end registration projects, including documentation, submission, and liaison with regulatory bodies.
· Be the primary contact person for the certificate registration, leading local certification processes and ensuring compliance with each country’s requirements.
· Work closely with local/international project team or on-site Regulatory leads to plan and align submission strategies.
· Coordinate with internal teams (Lab, QA, Operations, Legal,…) and external consultants for dossier preparation.
· Monitor regulatory changes, assess impact, and provide guidance for certification maintenance.
· Track project timelines and budgets; escalate deviations and propose mitigation plans.
· Provide progress updates and reports to senior management and stakeholders.
Job Requirements
· Bachelor’s degree in Biotechnology, Life Sciences, Pharmacy, or related field. Master’s preferred.
· 5+ years in biotech/pharma regulatory affairs, particularly with CAP/FDA/HSA/NMPA submissions in Asia.
· Proven track record in managing international certification projects and engaging with health authorities.
· In-depth knowledge of regulatory frameworks in at least one or two APAC countries.
· Excellent project management abilities, attention to detail, and organizational skills.
· Strong communication and collaboration skills across cross-functional teams and countries.
· Fluency in English. Additional regional languages (e.g., Mandarin) is a plus.
#J-18808-LjbffrDirector Regulatory Affairs

Posted 15 days ago
Job Viewed
Job Description
**Main Responsibilities**
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
**Strategic Planning:**
+ Identify need for new regulatory policies, processes and SOPs and approve them.
+ Develop and advance the organization's policy and procedures for regulatory affairs and compliance to establish a compliant culture.
+ Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
+ Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
+ Develop global regulatory strategies and update based upon regulatory changes.
+ Anticipate emerging issues and develop solutions to them.
+ Develop solutions to address issues with other members of management and stakeholders.
+ Develop corporate positions on regulatory risk-benefit.
+ Create and develop product positioning strategies based upon regulatory requirements.
+ Integrate regulatory considerations into the corporation's global product entry and exit strategy.
+ Provide guidance for resource and development planning.
+ Participate in applicable trade association/industry working groups to influence policy/rulemaking in alignment with business strategies Pre-market.
+ Communicate application progress to internal stakeholders.
+ Negotiate with regulatory authorities during the development and review process to ensure submission approval.
+ Provide strategic input and technical guidance on regulatory requirements to development teams.
+ Ensure pre-approval compliance activities are completed.
+ Formulate company procedures to respond to regulatory authority queries postmarked.
+ Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests.
+ Ensure a system is in place to manage access to information requests.
+ Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance.
+ Identify and present option for risk mitigation to decision makers.
+ Ensure adverse events are reported to regulatory agencies and internal stakeholders.
+ Manage processes involved with maintaining annual licenses, registrations, listings and patent information.
+ Ensure compliance with product post-marketing approval requirements.
+ Review and approve advertising and promotional items to ensure regulatory compliance.
**Job specific responsibilities may include**
+ Country-specific regulatory support, including the SEA market.
**Accountability**
+ Scope is division-wide regulatory direction for product development and support to develop most rapid successful strategy for approval to market products to meet business objectives; administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions; attract and develop superior regulatory professionals and regulatory competencies.
+ Must assure that all deadlines are met and provide effective leadership without direct authority.
+ Individual is recognized as a key opinion leader and resource in regulatory affairs.
**Influence/Leadership:**
+ Develops, communicates, and builds consensus for operating goals that are in alignment with the division and corporation
+ Provides leadership by communicating and providing guidance towards achieving department, division and/or corporate objectives
+ Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units
+ May lead a project team or initiative within department or cross-functions/divisions
+ Provides technical leadership to business units
+ Exercises judgment independently
+ Leads assigned departments by developing, communicating, and building consensus for goals and programs that support division, business unit and company objectives
+ May participate / lead external industry working groups to influence advocacy in alignment with business strategies
**Planning/Organization:**
+ Creates mid- to long-range plans to carry out objectives established by top management
+ Develops and calculates a budget for one or more departments to meet organizational goals
+ Forecasts future departmental or group needs including human and material resources and capital expenditures
+ Determines and establishes organizational structure and supervisory relationships subject to top management approval
**Decision Making/Impact:**
+ Assignments are expressed in the form of objectives
+ Work is performed without appreciable direction
+ Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.
+ Consequences of erroneous decisions or recommendations would normally include delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity
**Requirements**
+ Bachelor's degree (or equivalent); bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
+ Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 12+ years' experience in a regulated industry (e.g., medical products, nutritional). 12+ years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
+ Regulatory history, guidelines, policies, standards, practices, requirements and precedents
+ Regulatory agency structure, processes and key personnel
+ Principles and requirements of applicable product laws
+ Submission/registration types and requirements
+ GxPs (GCPs, GLPs, GMPs)
+ Principles and requirements of promotion, advertising and labeling
+ International treaties and regional, national, local and territorial trade requirements, agreements and considerations
+ Domestic and international regulatory guidelines, policies and regulations
+ Ethical guidelines of the regulatory profession, clinical research and regulatory process.
+ Monitor costs of projects and of human and material resources within a department or unit
+ Monitor company-wide indicators such as market share and profitability
+ Develop least cost, least time means to provide optimal regulatory support for new products
+ Monitor external environment in area of technical or professional responsibility
+ Direct and manage the preparation of technical strategic regulatory documentation for agency submission
+ Communicate effectively verbally and in writing
+ Communicate with diverse audiences and personnel
+ Work with cross-functional teams
+ Work with people from various disciplines and cultures
+ Write and edit technical documents
+ Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies
+ Negotiate internally and externally with regulatory agencies and participate in political lobbying
+ Plan and conduct meetings
+ Demonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks
+ Effectively negotiate regulatory agreements with global regulatory agencies
+ Negotiate regulatory and scientific issues with management
+ Adjust presentation style and content to suit the audience
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email