PW-6742 Senior CMC Manager, Global Regulatory Affairs
Closing Date: 11 Nov 16
Salary (£): Competitive
A key role within a global pharma company offering an exciting product pipeline. As a pivotal member of the Global Regulatory Affairs team, you’ll provide strategic direction and assume accountability for CMC related activities and projects including IMPD-Q, Module 2/3 for MAA or license variations and responding to questions from health authorities.
- Mid-sized global research based pharmaceutical company
- Hertfordshire based
- Excellent working environment
- Have CMC accountability (global and/or regional) for assigned products and the quality of submissions assessed by health authorities.
- Lead the preparation of high quality submission documents (for example IMPD-Q, Module 2/3 for MAA or license variations and respond to questions from health authorities in a timely fashion).
- Understand the current CMC environment and prepare business for future risks.
- Provide guidance to the Global CMC group as a senior member of staff.
- Assumes regulatory accountability for the CMC aspects of the projects/products goals and objectives
- Provides oversight for the CMC components of all regulatory submissions (IND or CTA, NDA or MAA, amendments, variations, scientific advice briefing documents, CMC agency communications etc.) to ensure that quality documents are prepared in compliance with the applicable regulatory requirements
- Engages in regional/national health agency meetings for CMC related discussions
- Interacts with and Influences external stake holders
- Supports regulatory strategy and manages timelines to meet project needs
- Has responsibility that the approval of work submitted by any junior staff/ consultants relating to CMC aspects of submissions is demonstrated.
QUALIFICATIONS / EXPERIENCE REQUIRED
- College or University degree in an associated functional discipline (Chemistry or Pharmacy)
- Doctorate or higher degree desired (e.g. MSc, JD, Pharm D, or PhD in life sciences)
- Extensive CMC regulatory experience
- An accomplished working knowledge of both the formulation and analytical aspects of R&D in addition to the above regulatory experience
- A strong working knowledge of the application of the principles of chemistry to drug synthesis
- Experience of the development of solid, liquid and parenteral dosage forms, including process validation.
- Experience dealing with agencies, preparation of briefing documents and holding agency meetings relating to Quality issues.
For a confidential discussion please telephone Andrea Litovsky at AXESS Limited on 020 8560 2300. To apply, please send your CV to firstname.lastname@example.org quoting reference PW-6742.
Only candidates with EU work authorisation will be considered.
Senior Regulatory Affairs Manager, Senior CMC Regulatory Affairs Manager, Regulatory Affairs Manager, Regulatory Affairs Manager CMC, Regulatory Affairs Project Manager, CMC, Module 3, MAA, licence variations, global, Hertfordshire, regulatory submissions, CTA, post approval, Emerging Markets, EM, Hertfordshire, module 3
AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market
Visit us at www.axess.co.uk