Associate Director Regulatory Affairs
The Job Description
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 Associate Director, Regulatory Affairs will work broadly across the business leading regulatory compliance on marketed and developing products, devise regulatory strategies for submissions to the FDA, and provide exert regulatory guidance to the wider group and project teams.
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
- Regulatory Advisor to different business groups ensuring regulatory compliance at facilities and manufacturing sites
- Lead submissions to FDA (pre-BLA, BLA, pre-IND, IND)
- Ensure submission document readiness covering a range of documentation including; Ad and Promo materials, license applications, briefing packages.
- Devise 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 10 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.
