Executive Director, Regulatory Affairs – Global Regulatory Leader
New
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Summit Therapeutics Inc.Biopharmaceutical oncology
Remote USFull-TimeDirector
Salary$231,000 — $285,000 USD
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Job Details
- Experience
- 15+ years of experience in pharmaceutical/biotech regulatory activities; 10+ years of proven experience in a strategic leadership role.
- Required Skills
- Project Management
Requirements
- Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology); Masters or Doctorate preferred.
- Minimum of 15+ years of experience in pharmaceutical/biotech regulatory activities.
- Experience as lead regulatory product strategist in two or more major regions in addition to the US (e.g., EU, Japan, or China).
- Significant experience with direct involvement/leadership in marketing/license applications (e.g., BLA, NDA, MAA).
- Experience supporting regulatory approvals, product launches, and post-marketing efforts.
- Significant experience dealing with partners/collaborations directly.
- Minimum of 10+ years of proven experience in a strategic leadership role.
- Strong project management skills and experience interfacing with major government regulatory authorities.
- Ability to work in a fast-paced, demanding, and collaborative environment.
- Travel up to approximately 5%.
Responsibilities
- Lead global regulatory strategies for assigned products through all phases of development, product launches, and post-marketing efforts.
- Represent Regulatory Affairs in development collaborations and partnerships, including leading due diligence for BD activities.
- Lead cross-functional efforts with clinical, biostatistics, commercial, and medical affairs to inform study synopses and regulatory briefing documents.
- Direct the preparation and maintenance of risk assessment and mitigation strategies.
- Lead labeling strategy from initial license applications through post-marketing.
- Advise management on the impact of laws, regulations, and guidelines.
- Provide coaching and mentoring for regulatory team members and oversee direct reports.
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