J2963West SussexPharmaceutical PermanentDependent on experienceFull Time04/01/2017Regulatory Affairs
Regulatory Affairs – UK
Regulatory Affairs - Biologics
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Hyper Recruitment Solutions are currently looking for a Regulatory Affairs Team Leader to join a leading biological pharmaceutical company based in the West Sussex area. The purpose of the role is to lead the strategy and manage a team within Global Regulatory Affairs. As the Regulatory Affairs Team Leader you will be responsible for
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Team Leader will be varied however the key duties and responsibilities are as follows:
You will review and approve CTA/IND submission and maintenance documentation, ensuring high quality timely submissions / responses and follow-up of actions arising from regulatory authority commitments.
As the Regulatory Affairs Team Leader you will be responsible for the preparation & review new product dossiers and annual updates
You will approve labelling/packaging text, promotional reviews and communicate effectively with regulatory agencies and joint projects with CROs.
As the Regulatory Affairs Team Leader you will maintain existing licences impacted by change control CMC or safety updates, and coordinate regulatory intelligence for worldwide markets.
To be successful in your application to this exciting opportunity as the Regulatory Affairs Team Leader we are looking to identify the following on your profile and past history:
1. Relevant degree in a scientific discipline.
2. Proven experience in a global regulatory environment.
3. A working knowledge and practical experience with Module 3 variations or clinical trial applications.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to 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 scientists supporting science. We look forward to helping you with your next career moves.