Vice President, Regulatory Affairs
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Job Description
VP of Regulatory Affairs overseeing global regulatory strategies and submissions for oncology-focused biotech. Collaborating with cross-functional teams and managing alliance partnerships.
Responsibilities:
- Reporting to the Chief Development Officer, the Vice President of Regulatory Affairs / Alliance Management will serve as a senior regulatory leader.
- Responsible for developing and executing global regulatory strategies across the company’s pipeline.
- Oversee regulatory submissions and interactions with global health authorities.
- Ensure programs progress efficiently and compliantly from early development through approval and commercialization.
Requirements:
- 15+ years of regulatory affairs experience in biotech/pharma, with significant leadership in CDx or IVD development.
- Proven track record of successful regulatory submissions and approvals for CDx products, ideally in oncology.
- Expertise with major global submissions and late stage or approved programs
- Demonstrated success leading regulatory strategy for oncology therapeutics.
- Strong leadership, strategic thinking, and executive communication skills.
Benefits:
- medical, dental, and vision insurance
- 401(k) retirement savings plan
- generous paid time off (including a summer and winter company shutdown)
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