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Job Details

Regulatory Affairs Manager - CMC

Company: Regulatory Professionals
Location: Cambridge
Reference: JO-1810-418423
Closing Date: 29 Dec 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Regulatory Professionals is collaborating with one of the leading biotechnology companies who are actively looking for a Regulatory Affairs Manager - CMC to join their established team

Requirements:

Regulatory Affairs Manager - CMC

12 month contract

Cambridge or Uxbridge based

Regulatory Professionals is collaborating with one of the leading biotechnology companies who are actively looking for a Regulatory Affairs Manager - CMC to join their established team on a 12 month contract basis focusing on the EU and Emerging Markets.

Working directly with the Director of CMC across Europe you will be responsible for developing and executing CMC regulatory strategies for new MAA's and throughout the whole product lifecycle for EU or the extended EU region.

The ideal candidate will be a CMC specialist who has a breadth and depth of experience in CMC across the full lifecycle covering CTA's to post approval deviations.

Job Responsibilities include;

- Review the preparation of Module 2 & 3 CMC components
- Manage strategy and execution of all regulatory submissions including clinical trials, variations, extensions and marketing applications)
- Authoring and coordinating responses to questions across assigned products and countries
- Act as point of contact with local country regulatory staff

Candidate Requirements include;

- Life Sciences degree or equivalent
- 5-7 years related experience within Regulatory Affairs
- Prior specific CMC regulatory knowledge and experience
- Direct experience with EU and Emerging market applications - MAA & variations
- Creation and execution of regional regulatory strategies

If this position is of interest to yourself please give Sophie at Regulatory Professionals a call on 0118 952 2797 or alternatively forward your CV to sophie@regulatoryprofessionals.com.

Apply for this job: Regulatory Affairs Manager - CMC

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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