Head of Regulatory Affairs CMC
2 days ago
Head of Regulatory Affairs CMC
Location: Remote in Europe (with travel to HQ required)
About the job
We are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. They have achieved FDA success with a few of their programs, which have now been launched in markets around the world. The portfolio now ranges from preclinical to approved products, with multiple new indications currently being explored.
This role is an exciting opportunity to join as Head of Regulatory Affairs CMC. Reporting directly to the Global Head of Regulatory, you will play a pivotal role in ensuring compliance with global regulatory requirements while facilitating product approval and lifecycle management. You will lead a team of approx. 20 individuals, providing them with direction, coaching & motivation.
We are looking for candidates who have the below experience:
- Over 10 years’ experience in Regulatory CMC from the biopharma industry and expertise in biologics or antibody would be an advantage
- Orphan drugs experience would be desirable
- Team leadership experience is a must of this candidate, with strong experience in coaching and developing regulatory teams
- In depth knowledge of global regulatory CMC requirements, particularly within US and EU markets
- A clear passion & motivation for bringing rare disease treatments to patients with unmet medical need
Please apply with an up to date CV for consideration.
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