Regulatory Affairs Director
3 days ago
Proclinical Staffing is seeking a seasoned professional to lead strategic regulatory decisions for an innovative biotech portfolio.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with FDA and global regulations.
- Lead a growing team of regulatory professionals and provide guidance on regulatory pathways.
- Collaborate with cross-functional teams to drive business growth and ensure regulatory excellence.
- Manage IND/BLA submissions and ensure timely regulatory approvals.
- Stay up-to-date with changing regulatory landscapes and adapt strategies accordingly.
Requirements:
- 10+ years of experience in Regulatory Affairs, with a focus on biotech or pharma.
- Oncology/Immuno-Oncology expertise is a must.
- Strong knowledge of FDA and global regulations, with experience in IND/BLA submissions.
What We Offer:
- A competitive salary range of $280,000 to $300,000 per annum.
Proclinical Staffing is an equal opportunity employer and a specialist employment agency providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
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