Senior Director, Regulatory Affairs

The role

The Senior Director of Regulatory Affairs develops and implements global strategies to secure IND/CTA approvals and provides regulatory leadership for global marketing applications in oncology. This role leads global regulatory strategies for assigned products through all development phases.

What you will do

• Leads global regulatory strategies for assigned products/indications through all phases of development.
• Expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers.
• Advises management and cross-functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards.
• Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development.
• May lead the Labeling Regulatory Team for given product(s)/indication(s).
• Ensures corporate goals are met with respect to assigned projects.
• Provides coaching and mentoring for other regulatory members.
• May have direct reports and contributes to the performance management for other RA team members.
• May participate and take leadership roles in professional associations, industry, and trade groups.
• Follows budget allocations.

Required qualifications

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject
• 12+ years' experience in pharmaceutical regulatory activities
• Experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Japan, or China
• Drug development experience in US & EU
• 5+ years of proven experience in a strategic leadership role with strong project management skills
• Experience working in a cross-functional environment with multiple stakeholders and influencing cross-functional teams
• Experience interfacing with major government regulatory authorities
• Strong communication and proactive negotiation skills
• Ability to communicate complex ideas in an easily understandable way
• Ability to successfully work in a fast-paced, demanding and collaborative environment

Nice to have

• Masters or Doctorate

Benefits

• bonus
• stock
• benefits

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.