94 Regulatory Affairs Professionals jobs in Singapore
Regulatory Affairs
Posted today
Job Viewed
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
Director Regulatory Affairs
Posted 14 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
Regulatory Affairs Intern
Posted 24 days ago
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Job Description
- Support to the SG RA team in the preparation and uploading of UDI data in HSA portal.
- Assist in preparation for new product registrations and renewals by ensuring completeness in registrations dossiers.
- Collaborate on regional regulatory projects for Greater Asia.
- Maintain accurate records related to product registrations.
- Establish and maintain registration plans and registered product listings.
- Support with communications with external stakeholders such as government agencies, consultants, and distributors.
- Provide regulatory support to internal departments including Marketing, Quality Assurance, Technical Support, and Manufacturing
**Job Description**
**Work location: The Strategy Office**
**MAIN RESPONSIBILITIES:**
+ Support to the SG RA team in the preparation and uploading of UDI data in HSA portal.
+ Assist in preparation for new product registrations and renewals by ensuring completeness in registrations dossiers.
+ Collaborate on regional regulatory projects for Greater Asia.
+ Maintain accurate records related to product registrations.
+ Establish and maintain registration plans and registered product listings.
+ Support with communications with external stakeholders such as government agencies, consultants, and distributors.
+ Provide regulatory support to internal departments including Marketing, Quality Assurance, Technical Support, and Manufacturing.
**Job Requirements:**
+ Grad/Under Grad Bachelor's Degree in Science/Engineering related discipline;
+ Possess knowledge and understanding of UDI regulations in SG;
+ Good understanding of Medical Device Regulations and ISO standards;
+ Strong knowledge of Microsoft Office Suite (Word, Excel, PowerPoint);
+ Ability to work independently, and able to manage multiple priorities simultaneously
Required Skills
Optional Skills
.
**Primary Work Location**
SGP The Strategy
**Additional Locations**
**Work Shift**
SG Normal Office 0900-1800 (Singapore)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Regulatory Affairs Associate
Posted today
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Job Description
Reporting to the Regulatory Affairs Manager, you will be responsible for assisting in Regulatory Affairs activities for clinical trials and marketing authorisation.
Responsibilities
• Assist with submission of applications and variations for clinical trials and marketing authorisation across all pipelines
• Support regulatory assessment of submission requirements based on relevant regulations
• Assist with administrative work necessary to support regulatory activities
• Review and provide input for regulatory documents
• Support any other duties assigned
Qualifications
• Degree in Biological, Chemistry, or a related field
• No experience required. Must have an interest in Regulatory Affairs
• Keen learner with a strong attention to detail and organizational skills
• Proficiency in English (written and spoken) is required
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
We are seeking a highly motivated and organized Regulatory Affairs Specialist to fill this key role. The ideal candidate will have a strong attention to detail, excellent organizational skills, and the ability to work effectively in a fast-paced environment.
Main Responsibilities:
- Support submission of applications and variations for clinical trials and marketing authorisation across all pipelines
- Contribute to regulatory assessment of submission requirements based on relevant regulations
- Assist with administrative tasks necessary to support regulatory activities
- Review and provide input for regulatory documents
- Support additional duties as assigned
Key Qualifications:
- Degree in Biological, Chemistry, or a related field
- No prior experience is required. An interest in Regulatory Affairs is essential
- A keen learner with a strong attention to detail and organisational skills is required
- Proficiency in English (written and spoken) is mandatory
About the Role:
This is an exciting opportunity for someone looking to develop their career in Regulatory Affairs.
Associate Regulatory Affairs
Posted today
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Job Description
Quality Assurance
- Ensure products delivered meet legal and customers' requirements
- Drive the quality improvement programs and activities and seek for continuous improvement.
- Deal with process quality issues; and deal with customers' quality issues & enquiries.
- Monitor GMP & QA activities of the company for regulatory compliance
- Outline quality assurance policies and procedures
- Interpret and comply with quality assurance standards
- Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies
- Participates in Regulatory and Customer Audits.
- Oversee the implementation and ensure efficiency of inspection and quality systems
- Document quality assurance activities, such as internal audits
- Analyze customer grievances and other non-compliance issues
- Providing training for employees to ensure compliance with SOPs
- Analyze audit outcomes and carry out appropriate corrective procedures
- Set up and maintain pharmaceutical and medical device quality system in accordance with the company's quality policy
- Maintain a good documentation system for organizing controlled documents and retaining records of manufacture which enable the complete history of a batch to be traced, readily available and easily traceable
- Ensure established Quality Management System such as Product Complaint & Recall, Internal &External Audits, Vendor Management, Deviation Management, CAPA, Change Control and Quality Risk Management are effectively implemented, monitored and in compliance with cGMP / authority requirements
- Lead the formulation of registration strategy for products/projects. Ensures effective implementation of the strategies and adhere to corporate objectives and business goals.
- Regulatory knowledge: Maintains a high level of regulatory knowledge on global/regional regulatory requirements and provides regulatory guidance for global counterparts.
- Agency interactions: Acts as core point of contact to relevant authorities/external organizations (CROs, NBs, etc) for products/projects. Liaises, negotiates and lead interactions, including appropriate documentation of the interaction, decisions and outcomes.
- Dossier submissions: independently leads the preparation, coordination or monitoring or regulatory submissions. Interacts across APAC and global to obtain and/or provide information/data for regulatory submissions.
- Coordinates change control responses from APAC countries and stock build if required with supply chain department.
To be considered for this opportunity, please kindly apply with your updated CV.
Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502
Regulatory Affairs Specialist
Posted today
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Job Description
The role of a Regulatory Manager in the Asia Pacific region involves serving as the primary liaison between Head Quarters and partners on regulatory matters. Key responsibilities include coordinating queries, variations, submissions, and registrations; handling product issues or complaints, as well as quality issues; updating PDM and Packaging records; maintaining past dossiers and attending to queries relating to approved dossiers and dossier information; recording trademarks for APAC countries; maintaining GTIN information for products marketed in APAC countries; monitoring, reporting, and documenting ICSRs for products marketed in Singapore; executing recall procedures and documentation for products marketed in Singapore; coordinating recall procedures, execution, and documentation for products marketed in APAC countries in accordance with local regulatory requirements; preparing quarterly reports on weekly literature screening outcomes; reconciling ICSRs annually for Singapore; and coordinating with partners to reconcile ICSRs for their respective countries. Additionally, pharmacovigilance training is required, and the Local Safety Officer will serve in liaison with the Pharmacovigilance Department in HQ. Submission of Product Quality Reports and Periodic Safety Update Reports is also necessary where legally required.
Requirements- A degree in Pharmacy, Biology, Chemistry, or a related field is essential.
- 3-5 years of experience in regulatory affairs, preferably in herbal or pharmaceutical products, are preferred.
- Strong attention to detail and organizational skills are crucial.
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Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
About the Role:
The primary responsibility of this position is to manage regulatory affairs and product registrations for all SciMed products.
This includes being the key point of contact for advice on regulatory guidelines and activities. Additionally, the candidate will 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.
Key Responsibilities:
- Manage regulatory affairs and product registrations for all SciMed products
- Provide guidance on regulatory guidelines and activities
- SUPPORT THE MANAGEMENT REPRESENTATIVE IN ENSURING AN EFFECTIVE QUALITY MANAGEMENT SYSTEM (QMS)
Requirements:
To be successful in this role, you will need to have a strong understanding of regulatory affairs and quality management systems. You should also have excellent communication and interpersonal skills, as well as the ability to work independently and as part of a team.
Benefits:
We offer a competitive salary and benefits package, including opportunities for professional development and growth.
Why Join Us:
We are a dynamic and forward-thinking organization that values innovation and excellence. If you are a motivated and talented individual who is passionate about regulatory affairs, we would love to hear from you.
Regulatory Affairs Director
Posted today
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Job Description
Are you passionate about regulatory affairs? Do you have the expertise to lead and drive strategic regulatory initiatives? We are looking for a Regulatory Affairs Director to join our team in Region APAC (Asia Pacific) based in Singapore. If you are ready to make a significant impact and ensure timely regulatory approvals, read more and apply today for a life-changing career.
About the department
You will join our Regulatory Affairs team in Region APAC, based in Singapore. Our team is responsible for ensuring regulatory compliance for new products and product amendments, thereby keeping our license to operate. We work closely with health authorities and policymakers to shape future regulatory frameworks and ensure the safety of our medicines. The atmosphere in our department is dynamic and collaborative, with a strong focus on capability building and development.
The position
In this role you, you will be responsible for ensuring the Region APAC regulatory strategic direction enables the regional commercial success, by obtaining timely regulatory approvals with optimal product claims and facilitating optimal launch conditions for new products and life cycle improvements across the region.
Among your main responsibilities will be:
- Developing and driving the strategic direction for the Regulatory Affairs function in Region APAC to ensure alignment with business needs and timely regulatory approvals. Offering strategic regulatory expertise to key counterparts to ensure commercial success aligned with corporate strategies and priorities.
- Ensuring that the Region APAC strategy, priorities, and regulatory needs are reflected in global Regulatory Affairs and International Operations strategies. Providing regulatory expertise, leadership, and consultation to identify and address regional business opportunities from a Regulatory Affairs perspective.
- Maximizing the synergies of the regulatory function within Region APAC Clinical & Regulatory function and strengthen RA partnerships with key stakeholders.
- Engaging in capability building and further development of regulatory staff across Region APAC to enhance efficiency and competencies.
- Leading regulatory policy and advocacy activities across Region APAC and represent NN towards external stakeholders and fora.
Qualifications
- University degree (Pharmaceutical, medical/life science related field or relevant business orientation); a relevant Post Graduate degree (e.g. PhD, MBA, or MSc) would be a plus.
- 7–10 years of relevant international experience in the Pharmaceutical Industry in a Regulatory role.
- People management experience with both strategic and operational leadership responsibilities.
- Strong communication skills and profound stakeholder management capabilities.
- Robust enterprise mindset with a focus on setting strategic direction and proactive planning.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we're all here - to ensure that people can lead a life independent of chronic disease.
Tell employers what skills you havePharmaceutical Industry
Management Skills
Clinical
Leadership
Regulatory Compliance
Regulatory Affairs
Capacity Building
Strategy
Advocacy
Communication Skills
Pharmacology
Regional experience
Life Sciences
Stakeholder Management
People Management Experience
Regulatory Affairs Associate
Posted today
Job Viewed
Job Description
Job Description & Requirements
Reporting to the Regulatory Affairs Manager, you will be responsible for assisting in Regulatory Affairs activities for clinical trials and marketing authorisation.
Responsibilities
· Assist with submission of applications and variations for clinical trials and marketing authorisation across all pipelines
· Support regulatory assessment of submission requirements based on relevant regulations
· Assist with administrative work necessary to support regulatory activities
· Review and provide input for regulatory documents
· Support any other duties assigned
Qualifications
· Degree in Biological, Chemistry, or a related field
· No experience required. Must have an interest in Regulatory Affairs
· Keen learner with a strong attention to detail and organizational skills
· Proficiency in English (written and spoken) is required
Tell employers what skills you haveEnglish Language
resourceful
Regulatory Compliance
Strong Attention To Detail
Regulatory Affairs
Chemistry
Clinical Trials
Biology
Organization Skills
Team Player