Reference Number: JO-2302-510060
Senior/Manager Regulatory CMC
Job Type: Permanent
Location: Central London / West End
Job Title: Senior Manager, Regulatory Affairs CMC
Location: London – Hybrid working
Salary: £65,000 – £80,000 plus package
CPL Life Sciences are partnered with an international pharmaceutical business, who are going through a period of growth and are now looking for an experienced Senior Manager or Manager level Regulatory CMC professional to join the team.
This role will work across the companies established product portfolio as well supporting their developing pipeline across the EU and RoW markets, covering small molecule and biologic products.
With an exciting developing pipeline of biologic products and some exciting partnership projects upcoming, this is a fantastic opportunity for a career minded individual who is keen to establish themselves within a growing business.
· Strong experience of small molecule dosage forms, particularly sterile and oral products. Familiarity with biological products will be an advantage.
· Experience with preparation of documentation for minor and major CMC post-approval variations.
· Experience of extension applications for new strengths and/or pharmaceutical dosage forms.
· Experience with EU submissions via the Centralised Procedure.
· Demonstrable knowledge of EMA and ICH regulatory CMC/Quality guidelines
· Experience supporting the preparation of CMC documentation for IMPDs, new product EU MAAs and PIPs will be an advantage.
· Direct agency interactions and preparation of scientific advice briefing documents for CMC related content and/or questions will be an advantage.
If you’d like to learn more about the opportunity, please apply with an updated copy of your CV and I will be in touch to discuss this further – email@example.com