Global Regulatory Strategy Lead – Oncology

Summit Therapeutics; United States; Remote; USD 203,000 - 253,000; Full time

Job summary

Summit Therapeutics is seeking a Senior Director of Regulatory Affairs to develop and implement global strategies to secure IND/CTA approvals and lead planning for global marketing applications (BLA/MAA) in oncology. You will guide regulatory dossiers, collaborate with partners, and mentor regulatory team members across major regions including US and EU.

You will lead cross-functional teams, evaluate regulatory requirements, and influence stakeholders while ensuring timely submissions and

Qualifications

• 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, with experience as lead regulatory product strategist in two or more major regions in addition to the US
• Experience and direct involvement as related to marketing/license applications (e.g., BLA, NDA, MAA)
• Requires drug development experience in US & EU
• Minimum of 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
• Communicate effectively and articulate complex ideas in an easily understandable way
• Ability to successfully work in a fast-paced, demanding and collaborative environment
• Travel up to approximately 5%

Responsibilities

• Leads global regulatory strategies for assigned products/indications through all phases of development
• May be asked to support Regulatory Affairs as relates to development collaborations and/or partnerships and be the primary point of contact for Summit regulatory to ensure success of partner IND/CTA requirements for studies sponsored by partner
• Continually 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
• May lead the Labeling Regulatory Team for given product(s)/indication(s)
• Demonstrates excellent understanding of drug development and leadership behaviors consistent with level
• Accountable for ensuring that corporate goals are met with respect to assigned projects
• Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members
• May have direct reports and contributes to the performance management for other RA team members
• May advance the organization’s goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate
• Follows budget allocations

Skills

Regulatory leadership

Global regulatory strategy

Cross-functional collaboration

Stakeholder management

Communication skills

Budget awareness

Education

Bachelor in life sciences

Masters or Doctorate preferred

Job description

Summit Therapeutics is seeking a Senior Director of Regulatory Affairs to develop and implement global strategies to secure IND/CTA approvals and lead planning for global marketing applications (BLA/MAA) in oncology. You will guide regulatory dossiers, collaborate with partners, and mentor regulatory team members across major regions including US and EU.

You will lead cross-functional teams, evaluate regulatory requirements, and influence stakeholders while ensuring timely submissions and