185 Regulatory Affairs Associate jobs in Singapore

Associate Director, Regulatory Affairs, JAPAC

AbbVie

Posted 13 days ago

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Job Description

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Primary Function / Primary Goals / Objectives:
The Associate Director, Regulatory Affairs (RA) serves as the primary JAPAC representative of the regulatory affairs function within both the R&D and commercial organizations for all matters related to assigned therapeutic areas and products. The incumbent is responsible for defining, implementing, and delivering Area and Affiliate regulatory strategies across a portfolio of compounds spanning early development, late development, and marketed products within the JAPAC region. With deep expertise in regional regulatory requirements, the role acts as a subject matter expert for assigned countries, continuously monitoring, interpreting, and influencing changes in regulatory policy and intelligence relevant to those markets. In addition, the incumbent represents the RA function in cross-functional initiatives and mentors and develops regulatory team for the assigned therapeutic areas and products.
Major Responsibilities:
+ Provide mentorship and development to team members, fostering a collaborative and high-performance culture; represent Therapeutic Area Head at assigned internal and external meetings and initiatives.
+ Lead and execute regional Regulatory Affairs (RA) initiatives for JAPAC in partnership with global, area, and affiliate teams; ensure timely project completion and efficient communication and implementation of plans.
+ Serve as the primary RA liaison to affiliate teams for assigned programs, maintaining clear and productive communication channels.
+ Serve as primary RA point of contact with local health authorities (through affiliate RA personnel); prepare teams for agency consultations by aligning briefing materials with the regulatory strategy, and ensure outcomes are communicated promptly to stakeholders.
+ Assess and review scientific and technical data provided by subject matter experts for regulatory submissions, ensuring alignment with JAPAC and regional requirements, identifying gaps, and developing mitigation strategies as needed.
+ Effectively present regulatory data to RA affiliates and ensure complete and timely responses to authorities for Clinical trial applications, New Drug/ New indication applications and any other assigned applications.
+ Collaborate cross-functionally with Commercial, Medical Affairs, Market Access, Clinical Development, and CMC teams, represent the regulatory function and provide strategic input to enable product registrations, mitigate regulatory risks, and ensure compliance.
+ Develops Area Regulatory Strategy and implements Regulatory Plan for assigned projects in JAPAC region in conjunction with the Global Regulatory Lead, RA Affiliate team and RA submission management.
+ Represent regional and affiliate regulatory strategies and requirements in Global Regulatory Product Teams (GRPT), ensuring alignment across global, regional, and local stakeholders and regulatory leadership forums.
+ Monitor and analyze trends in the regional regulatory environment and emerging policies; provide updates, assess business implications, and develop strategies to address regulatory changes affecting product portfolios.
+ Support R&D, affiliate regulatory teams, and clinical operations in achieving timely approvals for clinical trials applications.
+ Lead development and delivery of training programs to build regional RA capability and ensure ongoing team development.
+ Oversee regulatory compliance for assigned products/compounds in JAPAC; support implementation and monitoring of remediation plans to address identified compliance gaps.
+ Proactively identify, escalate, and manage regulatory risks throughout the product life cycle, recommending solutions to management as required.
+ May participate in due diligence, portfolio planning, or integration activities to support business expansion or product acquisitions.
+ Contribute to process improvement initiatives within the RA function and foster a culture of continuous improvement, knowledge sharing, and best practices.
Qualifications
Education / Experience Required:
+ Bachelor's degree in pharmacy, Pharmacology, Biology, or a related scientific discipline (advanced degree preferred).
+ Minimum of 7 years' experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, with at least 5 years' hands-on experience in JAPAC regulatory affairs, End to End Experience with both Japan and China New Drug Registrations, Health Authority Interactions and Clinical Trial Applications, with strong sensitivity and understanding of the cultural and business practices across the JAPAC region.
+ Comprehensive knowledge of the regulatory requirements and processes across JAPAC countries, with demonstrated expertise in navigating local regulations, submissions, and health authority interactions.
+ Early development experience beginning with Phase 1 clinical trials, including exposure to adaptive clinical trial designs.
+ 1-2 years of recent Regulatory experience with medical devices and/ or combination products
+ Experience working with Immunology compounds is preferred.
+ Proven track record of supporting capability development and team growth within Regulatory Affairs.
+ Solid business acumen developed through participation in cross-functional projects and assignments.
+ Experience in resource planning, line management, or direct team leadership is advantageous.
+ Demonstrated interpersonal and influencing skills, with a proven ability to communicate strategic and tactical regulatory issues clearly to management and diverse stakeholders.
+ Strong personal development and motivational skills; committed to ongoing professional growth and supporting the growth of others.
+ Ability to work independently, manage multiple priorities, and deliver high-quality outcomes in a dynamic, fast-paced, and cross-cultural environment.
Accountability / Scope:
+ The incumbent is accountable for representing RA to the area commercial organization and ensuring that business priorities are communicated and integrated into the global regulatory strategies.
+ The incumbent acts as the representative for RA on the cross-functional teams for the Area.
+ The incumbent is expected to communicate changes in regulatory requirements that may impact on the data requirements or timelines for gaining and/or maintaining marketing authorization applications.
+ The incumbent will:
+ Deputize the Therapeutic Area Head for Assigned Projects
+ ensure prioritization of regulatory plans and execute those in line with business priorities.
+ manage the assigned compounds and projects
+ mentor the team with respect to technical and leadership capabilities.
Problem Solving:
+ The incumbent is expected to be able to identify potential issues that may impact the regulatory strategy and timeline for assigned projects/products and to develop solutions to mitigate the risk and outcome.
+ The incumbent should have strong communication and negotiation skills to reach mutually agreeable solutions on issues with regulatory agencies, affiliates and regional cross functional stakeholders.
+ The incumbent is expected to monitor the regulatory landscape and to identify trends within the region that may have a material impact to the business and adapt strategies where necessary
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Regulatory Submissions (Study Start-up) Manager

Singapore, Singapore Medpace

Posted today

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Job Description

Job Summary
We are currently seeking a full-time Study Start Up Submissions Manager to join our Clinical Operations team in Singapore.
Responsibilities
Efficiently manage and successfully execute all aspects of global start-up;
Perform quality checks on submission documents and site essential documents;
Prepare and approve informed consent forms;
Review pertinent regulations to develop proactive solutions to start-up issues and challenges;
Present during bid defenses, general capabilities meetings, and audits.
Qualifications
More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
Regional experience will be highly advantageous;
Strong oral and written communication skills.
Travel: Minimal
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Compliance, Regulatory Country Compliance - Affairs, Analyst/Associate, Singapore Singapore · S[...]

Singapore, Singapore Goldman Sachs Bank AG

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Job Description

OUR IMPACT
Our division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm’s culture of compliance. Compliance accomplishes these through the firm’s enterprise-wide compliance risk management program. As an independent control function and part of the firm’s second line of defense, Compliance assesses the firm’s compliance, regulatory and reputational risk; monitors for compliance with new or amended laws, rules and regulations; designs and implements controls, policies, procedures and training; conducts independent testing; investigates, surveils and monitors for compliance risks and breaches; and leads the firm’s responses to regulatory examinations, audits and inquiries. You'll be part of a team with members from a wide range of academic and professional backgrounds, such as law, accounting, sales, and trading. We look for those who possess sound judgment, curiosity, and are able to adapt to a changing regulatory landscape.
YOUR IMPACT
This Analyst/Associate level position is an integral member of the Regional Country Compliance team based in Singapore. The position focuses on (i) compliance with Monetary Authority of Singapore (MAS) regulations, (ii) Compliance responsibility on cross-divisional, regional and/or global initiatives which impact Singapore. The person will work closely with divisional compliance teams in Singapore and in regional offices, and other control groups (such as Legal, Controllers, Operations, Human Capital Management, etc.), in driving the initiatives and efforts. This covers a broad spectrum of responsibilities which comprise but are not limited to the following:
Responsibilities:
Implementation and ongoing oversight of country-wide centralized compliance programs across regulated entities in Singapore
Drive implementation of regulatory initiatives
Manage Compliance program and control uplifts in line with regulatory requirements
Manage regular and ad-hoc regulatory audits, surveys and questionnaires
Manage internal and external audit engagements
Track regulatory interactions, regulatory updates and regulatory focuses
Organise and manage responses to regulatory and industry consultations
Engage with industry bodies and participants on advocacy and updates
Manage corporate governance related matters for office leadership
Experience/Skills:
University degree
Min. 2 years' Compliance, legal, regulatory or other relevant financial services experience.
Proactive, Self-motivated, well-organized and Hands-on
Good interpersonal skills and effective written/oral communication skills.
Detail-oriented with ability to multitask, organize and prioritize.
ABOUT GOLDMAN SACHS
At Goldman Sachs, we commit our people, capital and ideas to help our clients, shareholders and the communities we serve to grow. Founded in 1869, we are a leading global investment banking, securities and investment management firm. Headquartered in New York, we maintain offices around the world.
We believe who you are makes you better at what you do. We're committed to fostering and advancing diversity and inclusion in our own workplace and beyond by ensuring every individual within our firm has a number of opportunities to grow professionally and personally, from our training and development opportunities and firmwide networks to benefits, wellness and personal finance offerings and mindfulness programs. Learn more about our culture, benefits, and people at GS.com/careers.
Healthcare & Medical Insurance
We offer a wide range of health and welfare programs that vary depending on office location. These generally include medical, dental, short-term disability, long-term disability, life, accidental death, labor accident and business travel accident insurance.
We offer competitive vacation policies based on employee level and office location. We promote time off from work to recharge by providing generous vacation entitlements and a minimum of three weeks expected vacation usage each year.
Financial Wellness & Retirement
We assist employees in saving and planning for retirement, offer financial support for higher education, and provide a number of benefits to help employees prepare for the unexpected. We offer live financial education and content on a variety of topics to address the spectrum of employees’ priorities.
Health Services
We offer a medical advocacy service for employees and family members facing critical health situations, and counseling and referral services through the Employee Assistance Program (EAP). We provide Global Medical, Security and Travel Assistance and a Workplace Ergonomics Program. We also offer state-of-the-art on-site health centers in certain offices.
Fitness
To encourage employees to live a healthy and active lifestyle, some of our offices feature on-site fitness centers. For eligible employees we typically reimburse fees paid for a fitness club membership or activity (up to a pre-approved amount).
Child Care & Family Care
We offer on-site child care centers that provide full-time and emergency back-up care, as well as mother and baby rooms and homework rooms. In every office, we provide advice and counseling services, expectant parent resources and transitional programs for parents returning from parental leave. Adoption, surrogacy, egg donation and egg retrieval stipends are also available.
Benefits at Goldman Sachs
Read more about the full suite of class-leading benefits our firm has to offer.
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Legal Assistant

Singapore, Singapore $40000 - $60000 Y Shopee

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Job Description

Department Legal

LevelEntry Level

LocationSingapore

The Legal, Compliance and Finance teams play a key role in ensuring Shopee complies with applicable regulations and is primed for success with the right checks and balances while safeguarding the interests of our buyers and sellers in an inclusive and sustainable digital ecosystem. Browse our Legal, Compliance and Finance team openings to see how you can make an impact with us.

Job Description:

  • Draft and prepare standard corporate documents (e.g., board resolutions, shareholder resolutions, annual general meetings, minutes of meetings).
  • Assist in the formation and maintenance of legal entities and subsidiaries.
  • Coordinate and arrange execution of corporate documents.
  • Monitor and maintain calendar of regulatory and statutory filing deadlines (e.g., annual returns, annual general meetings).
  • Maintain statutory records, registers, and minute books.
  • Assist in the execution of contracts, including tracking signatures and filing fully executed agreements.
  • Collaborate with other departments and external parties where necessary
  • Other related tasks assigned from time to time

Requirements:

  • A minimum of 2-3 years of corporate secretarial experience
  • Highly ethical, discreet and able to maintain confidentiality
  • Meticulous, organized and committed to delivering high-quality work
  • Able to manage a large amount of paperwork, multitask and work in a dynamic and fast-paced environment
  • Proficient in MS Office applications
  • Excellent communication and interpersonal skills
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Legal Assistant

Singapore, Singapore beBeeParalegal

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Job Description

Job Title: Legal Assistant

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Job Description:

  • Support legal professionals by conducting research, drafting and preparing court documents.
  • Assist with electronic litigation functions, including filing and monitoring court cases, as well as maintaining and updating calendars for lawyers.
  • Contribute to case-related tasks, such as taking meeting minutes, assisting in witness interviews, and attending site inspections.

Requirements:

  • Hold a diploma in law (minimum requirement) or a law degree.
  • Minimum 1 year of experience required; 2-3 years of experience preferred.
  • Proficiency in spoken and written English is essential.
  • Strong skills in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
  • Able to work effectively under pressure.
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Legal Assistant

Singapore, Singapore K PRASAD & CO

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Job Description

Legal Assistant / Executive

We are a well-established boutique law firm in Singapore, seeking a dedicated and resourceful Legal Assistant / Executive to join our growing team. This role is ideal for individuals who are detail-oriented, proactive, and looking to contribute meaningfully in a close-knit legal environment.

Key Responsibilities
  • Provide administrative and legal support to lawyers
  • Prepare, file, and manage legal documents and correspondence
  • Handle client communications and maintain case files
  • Conduct basic legal research when required
  • Coordinate hearings, meetings, and schedules
  • Perform general office duties and assist with billing and file management
Requirements
  • Prior experience in a legal or administrative role preferred
  • Good written and spoken English
  • Proficient in Microsoft Office (Word, Excel, Outlook)
  • Strong organizational and communication skills
  • Ability to work independently and manage multiple tasks
  • Familiarity with Singapore legal procedures is an advantage
Location:

Flexible arrangements

Employment Type:

Part-Time / Full-Time

Eligibility:

Only Singapore Citizens or Permanent Residents may apply.
(We regret that only shortlisted candidates will be contacted.)

How to Apply

Please send your CV and a brief cover letter to , stating your availability and expected salary.
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Legal Assistant

Singapore, Singapore K PRASAD & CO

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Job Description

Roles & Responsibilities

Legal Assistant / Executive

We are a well-established boutique law firm in Singapore, seeking a dedicated and resourceful Legal Assistant / Executive to join our growing team. This role is ideal for individuals who are detail-oriented, proactive, and looking to contribute meaningfully in a close-knit legal environment.

Key Responsibilities
  • Provide administrative and legal support to lawyers
  • Prepare, file, and manage legal documents and correspondence
  • Handle client communications and maintain case files
  • Conduct basic legal research when required
  • Coordinate hearings, meetings, and schedules
  • Perform general office duties and assist with billing and file management
Requirements
  • Prior experience in a legal or administrative role preferred
  • Good written and spoken English
  • Proficient in Microsoft Office (Word, Excel, Outlook)
  • Strong organizational and communication skills
  • Ability to work independently and manage multiple tasks
  • Familiarity with Singapore legal procedures is an advantage
Location:

Flexible arrangements

Employment Type:

Part-Time / Full-Time

Eligibility:

Only Singapore Citizens or Permanent Residents may apply.

(We regret that only shortlisted candidates will be contacted.)

How to Apply

Please send your CV and a brief cover letter to , stating your availability and expected salary.

Tell employers what skills you have

Outlook
Microsoft Office
Legal Documents
Ability To Work Independently
Litigation
Legal Research
Hearings
Administration
Procurement
Communication Skills
Microsoft Word
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Legal Assistant

Singapore, Singapore K PRASAD & CO

Posted today

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Job Description

Legal Assistant / Executive
We are a well-established boutique law firm in Singapore, seeking a dedicated and resourceful Legal Assistant / Executive to join our growing team. This role is ideal for individuals who are detail-oriented, proactive, and looking to contribute meaningfully in a close-knit legal environment.
Key Responsibilities
  • Provide administrative and legal support to lawyers
  • Prepare, file, and manage legal documents and correspondence
  • Handle client communications and maintain case files
  • Conduct basic legal research when required
  • Coordinate hearings, meetings, and schedules
  • Perform general office duties and assist with billing and file management
Requirements
  • Prior experience in a legal or administrative role preferred
  • Good written and spoken English
  • Proficient in Microsoft Office (Word, Excel, Outlook)
  • Strong organizational and communication skills
  • Ability to work independently and manage multiple tasks
  • Familiarity with Singapore legal procedures is an advantage
Location:
Flexible arrangements
Employment Type:
Part-Time / Full-Time
Eligibility:
Only Singapore Citizens or Permanent Residents may apply.
(We regret that only shortlisted candidates will be contacted.)
How to Apply
Please send your CV and a brief cover letter to , stating your availability and expected salary.
This advertiser has chosen not to accept applicants from your region.

Legal Assistant

Singapore, Singapore Smart & Biggar LLP

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Overview
What We Do.
Smart & Biggar has been at the forefront of intellectual property (IP) and technology law for over 125 years. We practice in every area of IP on behalf of an exceptional international clientele, and we are consistently ranked as Canada’s leading IP firm. We are committed to hiring people with different backgrounds and experience, who represent the best talent in their field.
We are part of the IPH Group. IPH is the Asia Pacific’s leading intellectual property services group, comprising a network of member firms working in eight IP jurisdictions and servicing more than 25 countries. The group includes leading IP firms AJ Park, Griffith Hack, Pizzeys and Spruson & Ferguson and Smart & Biggar. IPH employs across Australia, China, Hong Kong SAR, Indonesia, Malaysia, New Zealand, Singapore, Thailand, and Canada.
We are passionate about what we do and what we can achieve. The IPH Group is committed to promoting and maintaining a workplace culture of shared respect across companies to enable us all to feel valued and be the best we can be.
The Opportunity
We are currently looking for
Legal Assistants
to join our national teams. In this role you will be part of our administrative team providing operational support to our patent or trademark agents and lawyers.
Responsibilities
Prepare and file patent or trademark correspondence and related documents with the Canadian Intellectual Property Office (CIPO)
Analyze documents received from the patent offices and write associated client reports
Track and ensure compliance with statutory and internal deadlines
Perform general administrative duties including creation of outgoing correspondence, time entry, preparation of invoices/billings and record management (in a paperless environment)
Prepare correspondence to clients, foreign associates, CIPO, and other parties as required
Other duties may be assigned or amended as required
Qualifications, competencies and experience
Legal or General Administrative Assistant Diploma
1-3 years’ experience as an assistant in a legal or professional services environment, previous experience with IP would be considered an asset
Excellent interpersonal and communication skills including the ability to deal directly with clients and all levels of staff
Excellent attention to detail, highly organized and proactive
Highly proficient in MS Office and ability to learn new software and technology quickly
#LI-HYBRID
Benefits
A comprehensive total rewards package including:
A competitive compensation structure based on transparency, clarity and fairness;
A flexible benefits program;
Personal days to help balance personal and professional commitments;
Employee referral program.
Smart & Biggar is a proud member of the Law Firm Diversity and Inclusion Network (LFDIN), working to promote diversity and encourage a culture of inclusion in our Firm and the broader legal profession.
We welcome applications from all qualified individuals. Accommodations are available on request for candidates taking part in all aspects of the selection process.
We thank all applicants in advance for their interest; however, only those candidates selected for an interview will be contacted.
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Legal Assistant

Singapore, Singapore Paradigm

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Job Description

Introduction
We are seeking a highly organized and efficient Legal Assistant to join our dynamic legal team. The ideal candidate will be an excellent communicator and project manager, with previous exposure to legal terminology and company secretarial work, and possess a minimum of three years of relevant experience in a legal setting. This role requires a professional who can facilitate the smooth operation of our legal office by providing comprehensive administrative support to our attorneys and company secretaries.
Key Responsibilities
Documentation and Database Management: Manage and organize case files, documents, and schedules of relevant legal counsels and team members to ensure timely responses and compliance with legal timelines.
Company Secretarial Work: Support the Company Secretary in statutory filings and document preparation, involving entities in Singapore and other jurisdiction.
Facilitate Internal and External Communication: Facilitate effective communication between legal team and external agencies, and between internal stakeholders, to ensure information is conveyed clearly and professionally. Support in process improvement to increase work efficiency of the team.
Research Support: Perform general market research as directed and compile data for business and legal references.
Project Management and Personal Assistance for Chief Legal Officer: Organize all project workstreams involving the Chief Legal Officer, facilitate progress and reminder for actions according to priorities and timelines. Support Chief Legal Officer in daily matters and scheduling where relevant.
Qualifications
Bachelor’s degree in legal studies, business administration, corporate governance, or equivalent. Relevant legal or paralegal certificate, or related field accreditations are plus points.
Minimum of three years of experience as a legal assistant or in a similar role within a legal environment. Must have company secretarial work exposure previously.
Exceptional organizational skills and attention to detail. Demonstrated ability to work independently as well as part of a team. Ability to work under pressure and meet tight deadlines.
Excellent verbal and written communication skills in both English and Chinese languages, able to facilitate work across multi-cultural and regional settings.
Why Join Us
Our firm offers a competitive salary, comprehensive benefits package, and a supportive work environment committed to professional growth and development. Join us to advance your career in a respected legal practice that values collaboration and excellence.
Application Process
Interested candidates should submit a resume outlining their qualifications and experiences related to the requirements and responsibilities of the role.
We look forward to receiving your application and exploring how your expertise and ambitions align with the goals of our legal team.
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