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Global Regulatory CMC Lead

BerkshirePermanent
Experience Dependant
Job Reference: J5633034
Updated On: 19/03/2020
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Biotechnology, Life Sciences

Skills: Regulatory Affairs - Permanent, Regulatory Affairs - EU, Regulatory Affairs - Global, Regulatory Affairs - CMC, Regulatory Affairs - Manager / Director / Executive, CMC - CMC - Regulatory, Regulatory Affairs - Biologics

Job Information

Role Overview

Hyper Recruitment Solutions have partnered with a leading Global Biopharmaceutical company based in Berkshire to identify their new Global Regulatory CMC Lead. This position sits within the company's Biologics division where you will lead all CMC activities including the management of projects during development through to MAA submission and life cycle maintenance.

Key Duties and Responsibilities

Your duties as the Global Regulatory CMC Lead will be varied however the key duties and responsibilities are as follows:

1. Define the strategy, planning and preparation of CMC documentation and sections for regulatory submissions from a global perspective. These include Briefing packages, Clinical Trial Applications, PIPs, MAA / BLA / NDA registrations and post-approval submissions.

2. Lead interactions with the Health Authorities including negotiation and resolution of CMC issues to facilitate the CMC approvals

3. Work cross functionally with Technical Teams and other departments to ensure Regulatory CMC information and activities are clearly communicated. You will work closely with the Global Regulatory Affairs Leadership teams and ensure strategy aligns with the rest of the business.

4. Manage a team of RA professionals and coach, mentor and train staff as required.

Role Requirements

Your duties as the Global Regulatory CMC Lead will be varied however the key duties and responsibilities are as follows:

1. Define the strategy, planning and preparation of CMC documentation and sections for regulatory submissions from a global perspective. These include Briefing packages, Clinical Trial Applications, PIPs, MAA / BLA / NDA registrations and post-approval submissions.

2. Lead interactions with the Health Authorities including negotiation and resolution of CMC issues to facilitate the CMC approvals

3. Work cross functionally with Technical Teams and other departments to ensure Regulatory CMC information and activities are clearly communicated. You will work closely with the Global Regulatory Affairs Leadership teams and ensure strategy aligns with the rest of the business.

4. Manage a team of RA professionals and coach, mentor and train staff as required.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Global Regulatory CMC Lead we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences discipline in addition to extensive Regulatory Affairs experience, ideally with some years experience of the Pharmaceutical industry in a Manufacturing, Analytical or Quality function.

2. Proven industry experience in working in Regulatory Affairs within a CMC focused role where you have successfully delivered on a range of projects from pre-MAA through to life cycle maintenance. Experience of leading Health Authority interactions is a must to be successful in this role.

3. A working knowledge and practical experience with Biological molecules will benefit your application to this position.

Key Words: Regulatory Affairs | Regulatory CMC | Global Regulatory Lead | GRA-CMC | Biologics | Biopharmaceutical | Module 3 | MAA | BLA | CTA | PIP | Scientific Advice | SA |
Georgia Walden
Your Recruitment ConsultantGeorgia WaldenGeorgia.walden@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.