Global Regulatory Strategy Manager
17 hours ago
Discover International is seeking a highly motivated Global Regulatory Strategy Manager to lead our regulatory affairs team. In this role, you will develop and execute comprehensive regulatory strategies for our cell and gene therapy products, ensuring successful approval and post-approval management.
The estimated annual salary for this position is $140,000 - $170,000, depending on experience. The ideal candidate will have a strong background in regulatory affairs and excellent leadership skills.
Key Responsibilities:
- Develop and execute comprehensive regulatory strategies for cell and gene therapy products.
- Lead the preparation, review, and submission of regulatory documents (INDs, BLAs, MAAs, etc.) to health authorities.
- Serve as the primary point of contact with global regulatory agencies (e.g., FDA, EMA) for assigned products.
- Cross-functional Collaboration: Partner with cross-functional teams to align on regulatory strategies and ensure coordinated efforts across the product lifecycle.
Qualifications:
Education:
- Bachelor's degree in life sciences, biotechnology, or a related field (required).
- Advanced degree (MS, PhD, PharmD) in a relevant field (preferred).
Experience:
- Minimum of 4-8 years of regulatory affairs experience in the biopharmaceutical industry.
- Proven track record of leading regulatory submissions and obtaining approvals for advanced therapies.
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