Senior Director, Regulatory Affairs
New
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Summit Therapeutics Inc.Biopharmaceutical Oncology
Location: (Remote US)Full-TimeDirector
Salary$203,000 — $253,000 USD
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Job Details
- Experience
- 10+ years' experience in pharmaceutical regulatory activities
- Required Skills
- Project Management
Requirements
- Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject; Masters or Doctorate preferred.
- Minimum of 10+ years' experience in pharmaceutical 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).
- Direct involvement in marketing/license applications (e.g., BLA, NDA, MAA).
- Drug development experience in US and EU.
- Minimum of 5+ years of strategic leadership experience with strong project management skills.
- Experience working in a cross-functional environment with multiple stakeholders.
- Experience interfacing with major government regulatory authorities.
- Strong communication and proactive negotiation skills.
- Ability to articulate complex ideas effectively.
- Ability to work in a fast-paced, demanding, and collaborative environment.
- Ability to travel up to approximately 5%.
Responsibilities
- Lead global regulatory strategies for assigned products and indications through all phases of development.
- Act as primary point of contact for regulatory requirements related to development collaborations and partnerships.
- Ensure strategic messaging and content of global regulatory dossiers, including tumor landscape assessment.
- Advise management and cross-functional teams on the impact of relevant laws, regulations, guidelines, and standards.
- Lead the Labeling Regulatory Team for assigned products and indications.
- Provide coaching and mentoring for other regulatory team members.
- Participate in professional associations, industry, and trade groups to advance organizational goals.
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