Regulatory Affairs Manager

Verbatim Pharma
Windsor
1 week ago
Applications closed

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Senior Regulatory Affairs Specialist - EMEA (Fully Remote, Worldwide)

Quality Control Manager

Quality Operations Project Manager

!*Observational Research Manager -Leading Biotechnology - Homebased in the UK!*

!*Observational Research Manager -Leading Biotechnology - Homebased in the UK!*

Quality Operations Project

This range is provided by Verbatim Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

Location:Windsor, UK

Industry:Pharmaceutical Services

Are you an experienced Regulatory Affairs professional looking for your next challenge? Our client, a global pharmaceutical services company, is seeking aGlobal Regulatory Affairs Managerto join our growing team. With over 25 years of experience serving life sciences companies worldwide, we specialize in clinical trial supply, logistics, and regulatory solutions.

The Role

As aGlobal Regulatory Affairs Manager, you will play a key role in supporting both internal teams and external clients with regulatory expertise. You will also contribute to the management of the regulatory intelligence database, ensuring compliance with evolving global regulations.

Key Responsibilities:

  1. Provide regulatory knowledge to supportEarly AccessandClinical Trial Supplybusiness units.
  2. Assist in theoperational delivery of regulatory services, including intelligence materials and regulatory plans.
  3. Supportprogramme leadsin developing and managing regulatory plans aligned with regional requirements.
  4. Overseesubmission planning, ensuring document accuracy and compliance across multiple regions.
  5. Maintain and manageregulatory archivesandintelligence databasesthat support business needs.
  6. Conductregulatory intelligence research, monitoring legislative changes and ensuring compliance.
  7. Analyze and translate newcountry-specific regulationsfor inclusion in regulatory databases.
  8. Researchlabelling and safety requirements, documenting findings in intelligence tools.

Minimum Requirements:

  1. Minimum 3 yearsof regulatory experience in thepharmaceutical industry(pharma company, CRO, or service provider).
  2. Experience inEarly AccessorClinical Trialsis a plus.
  3. Adegreein Natural Sciences (Biology, Biochemistry, Pharmacy) orQuality Management is desirable.
  4. Strong knowledge ofEU Directives, US CFR, and GMP/GDP regulations.
  5. Business fluent in Englishwith excellent communication skills.
  6. Aproactive team playerwith a pragmatic mindset and a company-wide perspective.

What makes this special?

  1. Work with aglobal leaderin pharmaceutical services.
  2. Be part of aninnovative and collaborativeteam.
  3. Contribute tostrategic regulatory initiativesthat impact global operations.
  4. Enjoy asupportive and dynamicwork environment.

Ready to advance your career inRegulatory Affairs? Apply today and be part of a company that drives excellence in global pharmaceutical services!

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Legal

Industries:Pharmaceutical Manufacturing

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