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Director Cmc Regulatory Affairs Biologics
3 weeks ago
DIRECTOR REGULATORY CMC | BIOLOGICS | EU / US / GLOBAL | NEUROLOGY
Looking for a Director CMC (Biologics) Regulatory Strategy to determine the CMC Regulatory activities to support the Neurology commercial product portfolio, and lead the CMC Regulatory team to deliver. This is an exciting strategic position with a innovativebiopharmaceutical company located in the UK.
**Responsibilities**:
- This is a global position where you will be responsible for the developing and implementing the Regulatory CMC Biologics strategy for the EU and US regions.
- Overall responsibility and leadership for the strategy of the CMC Regulatory filings, including authoring, coordination, review, and approval for the neurology commercial portfolio
- This is a business-critical position where you will work directly with the manufacturing sites and partner companies to ensure alignment, globally.
Skills required:
- Minimum of 10 years regulatory experience, strong biologics background
- In depth knowledge of EU & US Regulations pertaining to registration and lifecycle of biological products
- CMC experience in other global markets (China, Japan, Canada, etc.)
- Strong Regulatory writing experience and ability to summarize complex topics to senior stakeholders.
This is an initial 6 - month contract with scope to extend. This role offers hybrid/ remote working and is a full-time contract. There is a very attractive rate on offer.
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