We are currently looking for a Regulatory Affairs Specialist to join a leading Biopharmaceutical company based in the Wiltshire area. As the Regulatory Affairs Specialist you will act as Regulatory Lead and deputise for the Director of RA. You will focus on the life cycle maintenance of life changing products and will work closely with the Manufacturing and Quality team.
This position is perfect for a Regulatory Professional with experience of CMC documentation preparation, review and submission.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Specialist will be varied however the key duties and responsibilities are as follows:
1. Project Management of Regulatory activities with a primary focus on CMC modules where you will work closely with the Manufacturing and Quality teams in their GMP facilities.
2. Lead the management of regulatory licences and approvals as well as the management, preparation, submission and tracking of variations and renewals.
3. Directly liaise with regulatory authorities and respond to technical and administrative questions.
4. Manage regulatory change controls and provide Pharmacovigilance oversight.
To be successful in your application to this exciting opportunity as the Regulatory Affairs Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline e.g. Chemistry; Pharmacy; Pharmacology etc.) in addition to experience in the Pharmaceutical Industry.
2. Proven industry experience of working with Regulatory CMC documentation as well as having an understanding of GMP processes.
3. A working knowledge and practical experience with post marketing processes including variations and renewals.
Key Words: Regulatory Affairs | Post Marketing | Life Cycle Management | CMC | Module 3 | Biopharmaceutical | Pharmaceutical | GMP | Variations | Renewals | Regulatory Officer | Regulatory Associate | Regulatory Specialist
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 professionals and scientists. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Georgia Walden
- Phone: 0203 910 2980
- Reference: J5632454
- Posted: 31st October 2019
- Expires: 28th November 2019