66 matching jobs for “Manager CMC Regulatory Affairs”

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IQVIA Holdings

Regulatory Affairs Manager, Europe Biologic SME

Bucharest, Romania

Provide regulatory expertise for European market applications and post-marketing activities across the product lifecycle. …

Added Oct 15, 2026

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Viatris

Director Regulatory CMC Sciences Project Management

Northern Cross, Dublin, Ireland

Regular

& What You Will Be Doing The Director Reg. CMC Sciences Project Management is an emerging senior level position, recognized as a regulatory expert in the …

Added Oct 18, 2026

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Merck (MSD)

Associate Director , Regulatory Affairs

IND - Maharashtra - Pune (Wework)

Associate Director, Regulatory Affairs Registration of products for the Indian Market. To ensure compliance to all applicable laws and …

Added Oct 16, 2026

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IQVIA Holdings

Associate Program Director, Regulatory Affairs

Budapest, Hungary +3 locations 2 postings

Lead complex global Regulatory Affairs programs, ensuring successful delivery across multiple projects, workstreams and functional teams. …

Added Oct 15, 2026

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IQVIA Holdings

Associate Program Director, Regulatory Affairs

Warsaw, Poland

Lead complex global Regulatory Affairs programs, ensuring successful delivery across multiple projects, workstreams and functional teams. …

Added Oct 15, 2026

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Amgen

Senior Associate Clinical Trials Regulatory Affairs

Switzerland - Rotkreuz

Full time
Regular

… patients worldwide. It’s time for a career you can be proud of. Join us. SENIOR ASSOCIATE CLINICAL TRIALS REGULATORY AFFAIRS LIVE What you will do In this vital role as Senior Associate Clinical Trials Regulatory Affairs you …

Added Oct 15, 2026

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Pfizer

Regulatory Data Manager

Costa Rica - Escazu +2 locations

Full time
Regular

… drive appropriate system updates, notify stakeholders as needed, and collaborate with GRS stakeholders, CMC strategists, PGS, and cross-functional teams to understand and fulfill data requirements. Review and …

Added Oct 18, 2026

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Vertex Pharmaceuticals

CMC Statistics Director

Boston, Massachusetts, United States

Full time
Regular

Pay posted by employer$193,100–$289,700

General Summary : The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for the application of …

Added Oct 18, 2026

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Zoetis

Manager Regulatory Intelligence

US Remote

Full time
Regular

Pay posted by employer$120,000–$180,000

The manager leads the following workstreams: Global Surveillance Leadership (USA & Canada focus): Own and lead assigned …

Added Oct 23, 2026

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IQVIA Holdings

Director, Regulatory Affairs – Regenerative Medicine & Biologics Quality

Washington, District of Columbia, United States

Pay posted by employer$135,300–$376,800

include managing the development of regulatory submissions, development of overall regulatory strategy, communicating with regulatory bodies and clients, …

Added Oct 15, 2026

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Thermo Fisher Scientific

FSP RA - Client Dedicated - CMC Project Manager

Remote, Belgium

Join Us as a Regulatory Affairs Manager – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 …

Added Oct 22, 2026

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Vertex Pharmaceuticals

CMC Product Leader, Senior Director - T1D

Boston, Massachusetts, United States

Full time
Regular

Pay posted by employer$237,700–$356,500

General Summary: The Senior Director, CMC Product Leader (T1D) will lead the Chemistry, Manufacturing, and Controls (CMC) functional team supporting …

Added Oct 18, 2026

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Viatris

Senior Manager, European Regulatory Policy and Intelligence

Northern Cross, Dublin, Ireland

Regular

& What You Will Be Doing The Global Regulatory Policy and Intelligence (GRPI) team serves as strategic advisors to regulatory teams and other business …

Added Oct 18, 2026

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Vertex Pharmaceuticals

Regulatory Strategy Director, Renal

Paddington, United Kingdom

Full time
Regular

General Summary: The Regulatory Affairs Director will provide global regulatory leadership for programs within the Renal Therapy Team. This …

Added Oct 18, 2026

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Thermo Fisher Scientific

Labeling strategist - Reg Affairs AD

Remote, Belgium

Join Us as a Regulatory Affairs Associate Director- Labeling strategist – Make an Impact at the Forefront of Innovation We have …

Added Oct 16, 2026

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Pfizer

Regulatory Execution Hub Sr. Associate(1 Year Fixed Term)

Seoul, South Korea

Full time
Temporary

The RIO Execution Hub Associate/Sr Associate is responsible for providing regulatory support to the International country and/or cluster Regulatory teams. The Execution Hub Associates/Sr …

Added Oct 15, 2026

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Abbott Laboratories

Assistant Manager – Submission Publishing

Mumbai, India 2 postings

… contributor that works under limited supervision. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. …

Added Oct 15, 2026

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Johnson & Johnson

Manager - Analytical Development (Analytics)

Mumbai, India

… Job Sub-function: Pharmaceutical Product R&D Job Category: Scientific/Technology. We are searching for Manager-Analytics, DPDS-Synthetics based at our R&D facility in Mumbai, India. Role Purpose: We are seeking …

Added Oct 19, 2026

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Amgen

Manager, Product Lifecycle Management (LCM) Execution

Hyderabad, India

Full time
Regular

Manager, Product Lifecycle Management Execution ABOUT AMGEN Amgen harnesses the best of biology and technology to …

Added Oct 15, 2026

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IQVIA Holdings

Program Delivery Manager IP Administration

Durham, North Carolina, United States

Pay posted by employer$68,400–$171,000

… Deliverables: Services rendered will adhere to applicable Johnson & Johnson SOPs, Wis, policies, local regulatory requirements, etc. Co-author of the IPPI and review/provide input on all specific forms related to IP …

Added Oct 15, 2026

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IQVIA Holdings

Regulatory Affairs Manager, Europe Biologic SME

Bucharest, Romania

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What We're Looking For · employer excerpt

Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or another relevant scientific discipline.
At least 8 years of Regulatory Affairs experience.
Strong expertise in European regulatory requirements, procedures and submission pathways.
Proven experience supporting or managing market applications and post-marketing regulatory activities across the product lifecycle.
Strong knowledge of lifecycle management, variations, renewals and maintenance activities.

4 more in the full description below.

About this opportunity

Original employer description

At IQVIA, our Global Regulatory Affairs team partners with pharmaceutical and biotechnology companies worldwide to navigate complex regulatory environments and accelerate access to innovative therapies.

We are seeking an experienced Regulatory Affairs professional with deep expertise in European regulatory affairs and biologic products. This role is ideal for a senior regulatory specialist who enjoys managing complex market applications, lifecycle management activities and post-marketing submissions while acting as a trusted advisor to customers and internal stakeholders.

What You'll Do

Provide regulatory expertise for European market applications and post-marketing activities across the product lifecycle.
Support the development and execution of regulatory strategies for biologic products.
Prepare, coordinate and review regulatory submissions, including market applications, lifecycle management activities, labelling updates and CMC-related variations.
Support regulatory activities across Centralised, Decentralised, Mutual Recognition and national procedures.
Identify regulatory risks and provide practical recommendations to support successful project delivery.
Serve as a subject matter expert for post-marketing regulatory activities, including variations, renewals, maintenance activities and labelling changes.
Collaborate closely with CMC, clinical, safety, quality, labelling and project management stakeholders.
Participate in customer interactions, project meetings and governance discussions, providing clear regulatory guidance and recommendations.
Support continuous improvement initiatives and contribute to high-quality regulatory delivery across global programmes.
Ensure regulatory deliverables meet required quality, compliance and timeline expectations.

What We're Looking For

Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or another relevant scientific discipline.
At least 8 years of Regulatory Affairs experience.
Strong expertise in European regulatory requirements, procedures and submission pathways.
Proven experience supporting or managing market applications and post-marketing regulatory activities across the product lifecycle.
Strong knowledge of lifecycle management, variations, renewals and maintenance activities.
Experience managing labelling updates and CMC-related regulatory activities.
Experience working with biologic products is essential.
Ability to work independently as a regulatory subject matter expert within a matrixed and client-focused environment.
Excellent communication and stakeholder management skills.

Additional Experience That Will Help You Stand Out

Experience supporting complex European regulatory procedures.
Broad exposure to CMC regulatory activities.
Experience working within a CRO, consultancy or outsourced services environment.
Experience partnering with global cross-functional teams.
Customer-facing regulatory experience.
Experience supporting multiple products, markets or regulatory programmes simultaneously.

Why IQVIA?

Joining IQVIA means becoming part of a global team of regulatory experts supporting the development and lifecycle management of medicines that improve patient outcomes around the world.

In this role, you'll have the opportunity to:

Build deep expertise in biologics and European regulatory affairs.
Work on complex regulatory programmes across multiple markets.
Partner with leading pharmaceutical and biotechnology companies.
Collaborate with global experts across regulatory, quality, safety, clinical and CMC functions.
Contribute to innovative regulatory solutions in a highly collaborative environment.
Progress toward Associate Director, senior SME and broader Global Regulatory Affairs leadership opportunities.

If you are passionate about European Regulatory Affairs, biologics and lifecycle management, we'd love to hear from you.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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