Regulatory Affairs Strategist
4 days ago
Company Overview
">Discover International is a leading biopharmaceutical company dedicated to developing innovative cell and gene therapy products. Our mission is to improve patients' lives by delivering cutting-edge treatments.
We are seeking an experienced Senior Manager Regulatory Affairs to join our team in this pivotal role. The successful candidate will be responsible for leading regulatory strategies and ensuring the successful approval and post-approval management of our advanced therapies.
Job Summary
">This Senior Manager, Regulatory Affairs position plays a key role in shaping the regulatory strategy for our cell and gene therapy portfolio. The ideal candidate will have a proven track record of leading regulatory submissions and obtaining approvals for advanced therapies. Experience interacting with major global health authorities (FDA, EMA, etc.) is essential.
The successful candidate will collaborate closely with cross-functional teams to ensure compliance with global regulatory requirements, provide strategic regulatory guidance, and interact with regulatory agencies.
Responsibilities
">- Regulatory Strategy Development: Develop and execute comprehensive regulatory strategies for cell and gene therapy products, from early development through approval and life-cycle management, aligning with corporate objectives.
- Regulatory Submissions: Manage the preparation, review, and submission of regulatory documents (INDs, BLAs, MAAs, etc.) to health authorities, ensuring that submissions meet all regulatory requirements and timelines.
- Agency Interactions: Serve as the primary point of contact with global regulatory agencies (e.g., FDA, EMA) for assigned products, leading meetings, responding to agency questions, and negotiating on regulatory matters to facilitate product approvals.
- Cross-functional Collaboration: Partner with cross-functional teams, including clinical, CMC, quality, and commercial departments, to align on regulatory strategies and ensure coordinated efforts across the product lifecycle.
- Compliance and Monitoring: Stay current with evolving regulatory guidelines, particularly those pertaining to cell and gene therapies, and communicate relevant updates to the internal teams. Ensure ongoing compliance with regulatory requirements throughout the product lifecycle.
- Risk Management: Identify and evaluate regulatory risks, providing risk mitigation strategies and guidance on how to best approach regulatory challenges in the cell and gene therapy space.
- Team Leadership: Lead and mentor junior regulatory staff, fostering a collaborative environment that promotes knowledge sharing and professional development.
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 4-8 years of regulatory affairs experience in the biopharmaceutical industry, ideally with exposure to cell and gene therapy. Proven track record of leading regulatory submissions and obtaining approvals for advanced therapies. Extensive experience interacting with major global health authorities (FDA, EMA, etc.).
Salary: $120,000 - $150,000 per annum, depending on experience.
Benefits: Comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
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