66 matching jobs for “Manager CMC Regulatory Affairs”

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Abbott Laboratories

Manager - Regulatory Affairs

Mumbai, India

Primary Job Function: With Manager Support:- 1. Product registrations / Submissions -Actively leads product registrations by preparing/ …

Added Oct 15, 2026

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Regeneron Pharmaceuticals

Senior Specialist, CMC Regulatory Affairs - Quality Compliance

RENSS - GLOBAL VIEW

Full time
Regular

Pay posted by employer$78,700–$128,700

… to develop life-changing medicines for people with serious diseases. We are seeking a Senior Specialist, CMC Regulatory Affairs - Quality Compliance, to join our CMC Regulatory Affairs team, supporting our …

Added Oct 23, 2026

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Abbott Laboratories

Manager Regulatory Affairs

Mumbai, India

… Role Summarize the main purpose of the role Leads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function. First level manager of a work team that may comprise professionals, technical and/or …

Added Oct 15, 2026

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Regeneron Pharmaceuticals

Associate Director CMC Regulatory Affairs - Quality Compliance

RENSSELAER

Full time
Regular

Pay posted by employer$147,800–$241,200

… medicines for people with serious diseases. We are seeking an Associate Director, Quality Compliance, CMC Regulatory Affairs to join our CMC Regulatory Affairs team, supporting our manufacturing and supply …

Added Oct 22, 2026

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Thermo Fisher Scientific

Regulatory Affairs Manager

Remote, Germany +5 locations

Join Us as a Regulatory Affairs Manager As a Regulatory Affairs Manager, you'll offer innovative solutions, including regulatory …

Added Oct 16, 2026

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Viatris

Manager Regulatory CMC Sciences (Injectables)

Dublin-Office

Regular

… challenge to make a difference and here’s how the role will make an impact: Develop and implement global CMC regulatory strategies for injectable products. Interpret and communicate regulatory requirements and …

Added Oct 15, 2026

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Johnson & Johnson

[Innovative Medicine] R＆D, Scientist, CMC Group, CMC Sciences, Regulatory Affairs

Chiyoda, Japan

Full time
Regular

Position Summary To prepare application dossiers for CMC part and to communicate with HA appropriately to contribute in obtaining regulatory approval. To conduct …

Added Oct 15, 2026

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Viatris

Regulatory Affairs Manager - Central Regulatory Affairs (CRA), Europe

Lisbon, Portugal

Regular

… Role & What You Will Be Doing Every day, we rise to the challenge to make a difference, and here’s how the Regulatory Affairs Manager - Central Regulatory Affairs (CRA), Europe role will make an impact: Key responsibilities …

Added Oct 18, 2026

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Viatris

Regulatory Affairs Manager - Central Regulatory Affairs (CRA), Europe

Lisbon, Portugal

Regular

& What You Will Be Doing Every day, we rise to the challenge to make a difference, and here’s how the Regulatory Affairs Manager - Central Regulatory Affairs (CRA), Europe role will make an impact: Key responsibilities …

Added Oct 20, 2026

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Johnson & Johnson

Manager, Regulatory Affairs- Biomaterials

Raynham, Massachusetts, United States of America +1 location

Pay posted by employer$117,000–$201,250

… journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for a Manager, Regulatory Affairs – Biomaterials External Innovation to join our Orthopaedics team located in West …

Added Oct 18, 2026

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Abbott Laboratories

Assistant Manager -Regulatory Affairs

Mumbai, India

Job Description Core Job Responsibilities: With Manager Oversight and Supervision: Global Labeling Portfolio: Develops and maintains EPD Company Core Data Sheets …

Added Oct 20, 2026

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Abbott Laboratories

Assistant Manager– Regulatory Affairs

Mumbai, India

Core Job Responsibilities: With Manager Oversight and Supervision: Global Labeling Portfolio: Develops and maintains EPD Company Core Data Sheets …

Added Oct 15, 2026

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Viatris

Senior Manager, Regulatory Science CMC Complex

Northern Cross, Dublin, Ireland +1 location

Regular

& What You Will Be Doing Every day, we rise to the challenge to make a difference and here’s how the Senior Manager, Regulatory Science CMC Complex role will make an impact: Develop and execute global CMC regulatory …

Added Oct 15, 2026

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Johnson & Johnson

[Innovative Medicine] R＆D, Principal Scientist, CMC Group, CMC Sciences, Regulatory Affairs

Chiyoda, Japan

Full time
Regular

Position Summary To prepare application dossiers for CMC part and to communicate with HA appropriately to contribute in obtaining regulatory approval. To conduct …

Added Oct 15, 2026

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Regeneron Pharmaceuticals

Manager Combination Products - Regulatory Affairs

RENSSELAER +2 locations

Full time
Regular

Pay posted by employer$108,000–$176,000

… and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, Regulatory Affairs - Combination Products to join our Regulatory Affairs team, supporting our combination …

Added Oct 16, 2026

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Bristol-Myers Squibb

Senior Manager, Labeling & Regulatory Affairs

Otemachi-JP

Full time
Regular

… valuable new drugs and business continuity by providing and implementing optimal/valuable labeling and regulatory strategy in order to achieve BMSKK business target. For that objective, execute the following tasks; Have a …

Added Oct 15, 2026

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Amgen

EU Regulatory Affairs Manager (Biosimilars)

Uxbridge, United Kingdom +6 locations

Full time
Regular

… that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. EU REGULATORY AFFAIRS MANAGER - BIOSIMILARS LIVE What you will do In this vital role you will contribute to the …

Added Oct 15, 2026

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Merck (MSD)

Regulatory Affairs Manager- Animal Health

VNM - Ho Chi Minh - Ho Chi Minh City (Le Duan)

… to prevent supply-chain disruption or compliance gaps. Health Authority Liaison: Serve as the primary regulatory contact for competent Vietnam animal health authorities and other relevant government bodies; manage …

Added Oct 16, 2026

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Viatris

Regulatory Affairs Director - Central Regulatory Affairs (CRA), Europe

Lisbon, Portugal

Regular

… the impact we are making. Every day, we rise to the challenge to make a difference, and here’s how the Regulatory Affairs Director - Central Regulatory Affairs (CRA), Europe role will make an impact: By shaping and …

Added Oct 18, 2026

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Johnson & Johnson

Manager, APAC, Regulatory Affairs, Oncology

Singapore, Singapore +2 locations

Full time
Regular

… patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine POSITION SUMMARY: The Manager, APAC, Regulatory Affairs, Oncology is a member of the Global Regulatory Affairs organization. The position …

Added Oct 15, 2026

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Merck (MSD)

Regulatory Affairs Manager- Animal Health

VNM - Ho Chi Minh - Ho Chi Minh City (Le Duan)

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Experience · employer excerpt

Local Regulatory Expertise: Demonstrated experience engaging Vietnam’s competent animal health authorities and applying local veterinary medicinal-product registration, labeling, import/export, advertising, pharmacovigilance, and…
Matrix Collaboration: Proven effectiveness in a highly matrixed multinational environment, including cross-border collaboration with regional/global regulatory hubs and peers.
Work Style: Self-driven, detail-oriented, and able to work independently under tight timelines with minimal supervision.
Core Skills: Strong analytical and logical problem-solving capabilities; excellent cross-functional collaboration and negotiation skills.
Language: Native Vietnamese and professional-level written and spoken English.

About this opportunity

Original employer description

Job Description

Primary Responsibilities (but not limited to)

A. Registration & Lifecycle Management

New Product Approvals: Compile, review, translate, and submit high-quality registration dossiers for new biological and pharmaceutical products in accordance with local regulations, industry standards, and corporate guidelines.
Dossier Maintenance: Manage variations, extensions, and renewals of existing marketing authorizations to prevent supply-chain disruption or compliance gaps.
Health Authority Liaison: Serve as the primary regulatory contact for competent Vietnam animal health authorities and other relevant government bodies; manage submission follow-up, responses to authority questions, administrative issue resolution, and compliant working relationships.
Regulatory Operational Compliance: Manage product-standard conformity declarations and product labels; coordinate with internal and external stakeholders to obtain and maintain required import and export permits.

B. Regulatory Compliance & Technical Advisory

Regulatory Intelligence: Monitor, interpret, and communicate developments in local veterinary laws, standards, and regulatory trends to local and regional stakeholders.
Change Control & Promotional Material Review: Assess regulatory impact and support change-control processes. Review promotional, educational, digital, website, printed, and technical materials for alignment with local veterinary advertising requirements, global policies, and the company Code of Conduct. Provide documentation and advice for authority confirmation or submission, with operational ownership assigned under the approved local process.
Regulatory Records & Inspection Readiness: Maintain complete, accurate, and inspection-ready regulatory records, approvals, licenses, labels, commitments, and supporting documentation throughout the product lifecycle.

C. Pharmacovigilance (PV)

Country Pharmacovigilance Contact: Act as the designated Vietnam PV contact and maintain compliance with applicable global and local requirements.
Safety & Product Complaint Reporting: Ensure timely intake, documentation, entry, follow-up, escalation, and reporting of adverse events and product complaints under applicable procedures and timelines.
PV Procedures & Training: Prepare, implement, and maintain local PV procedures; deliver required training to employees and relevant business partners; and conduct awareness sessions as needed.
PV in Agreements & Studies: Ensure appropriate PV clauses in relevant agreements and study or trial protocols; coordinate required Global PV review and approval, train investigators or partners, and support safety-case entry and follow-up arising from post-marketing studies or other local activities.
Regional & Global Coordination: Partner with regional and global PV teams on case management, compliance monitoring, reporting obligations, reconciliation, and corrective actions.

D. Global, Regional & Cross-Border Collaboration

Global & Regional Alignment: Liaise with Global Regulatory Affairs and the Regional Regulatory Affairs Lead to align Vietnam strategies with the global pipeline and provide visibility of local timelines and registration roadblocks.
Process Optimization & Best-Practice Sharing: Collaborate with Regulatory Affairs Managers in other markets to share intelligence, exchange technical strategies, benchmark timelines, and implement standardized tools that improve submission outcomes.
Dossier Quality Harmonization: Partner with global CMC and biological/pharmaceutical R&D teams to refine dossier quality before local submission and promote a first-time-right approach.

Desired Experience/Education/Skills

Education: Bachelor’s degree or higher in Veterinary Medicine, Pharmacology, Animal Science, Biology, or a closely related scientific field.
Experience: Minimum six years of Regulatory Affairs experience in pharmaceutical, veterinary, or biotechnology sectors; direct animal-health experience preferred.
Local Regulatory Expertise: Demonstrated experience engaging Vietnam’s competent animal health authorities and applying local veterinary medicinal-product registration, labeling, import/export, advertising, pharmacovigilance, and lifecycle compliance requirements.
Matrix Collaboration: Proven effectiveness in a highly matrixed multinational environment, including cross-border collaboration with regional/global regulatory hubs and peers.
Work Style: Self-driven, detail-oriented, and able to work independently under tight timelines with minimal supervision.
Core Skills: Strong analytical and logical problem-solving capabilities; excellent cross-functional collaboration and negotiation skills.
Language: Native Vietnamese and professional-level written and spoken English.

Required Skills:

Regulatory Affairs Management, Regulatory Compliance, Regulatory Documents, Regulatory Inspections, Regulatory Processes, Regulatory Strategy Development

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

Hazardous Material(s):

N/A

Job Posting End Date:

10/26/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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