Regulatory Affairs Manager
My client is a market leading biopharma, developing and manufacturing innovative biologic immunotherapies using best-in-class patented processes, driving a new way forward for patients suffering with infectious diseases.
The Regulatory Affairs Manager will lead the preparation of regulatory submissions to the FDA, providing guidance on responses to questions, and regulatory compliance on marketed and developing assets.
With products already on the market and state of the art manufacturing capabilities, this is an exciting time to join a business in high growth mode, with a variety of career development paths available.
Responsibilities :
- Provide regulatory advice to cross functional project teams
- Prepare and review regulatory submissions (pre-BLA, BLA, pre-IND, IND)
- Ensure submission document readiness covering a range of documentation including; Ad and Promo materials, license applications, briefing packages.
- Support regulatory strategies liaising with SME’s when required
- Oversight of post marketing submissions through regulatory operations systems
Experience :
- Must have minimum of a Bachelor’s Degree
- Minimum 7 years of industry experience
- Experience submitting Biologic Licensing Applications (BLA)
- Must have Biologic’s experience, experience working with plasma derived products desirable
This is a pivotal role in the businesses continued growth therefore can offer above market salaries for the right candidate, and relocation packages / short term accommodation for candidates looking to move to the area.
Please apply with an updated version of your CV and I’ll be in touch to discuss further details.
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