Global Regulatory Strategy Lead, Oncology

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

Job summary

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on advancing innovative therapies to improve quality of life for patients with cancer.

The Senior Director of Regulatory Affairs will lead global regulatory strategies and drive IND/CTA approvals, with oversight of BLA/MAA planning for oncology products. Reporting to senior leadership, you will coordinate across functions, manage regulatory submissions in multiple regions, and mentor regulatory team members.

Qualifications

• Bachelor's degree in life sciences; Masters or Doctorate preferred.
• Minimum 10+ years in pharmaceutical regulatory activities with lead strategist experience in two or more regions including US.
• Experience with BLA, NDA, MAA submissions and regulatory approvals.
• At least 5+ years in a strategic leadership role with strong project management.
• Experience interfacing with major government regulatory authorities and stakeholders.
• Strong communication and negotiation skills; ability to influence cross-functional teams.

Responsibilities

• Lead global regulatory strategies for assigned products and indications across all development stages.
• Serve as primary contact for partner IND/CTA requirements and regulatory submissions.
• Develop tumor landscape assessments to inform development strategy and regulatory messaging.
• Provide regulatory leadership for planning and execution of global marketing applications (BLA/MAA).
• Mentor and coach regulatory team members; manage direct reports where applicable.
• Collaborate with senior leadership to ensure alignment with corporate goals and budgets.

Skills

Strategic leadership

Regulatory strategy

Cross-functional collaboration

Communication

Negotiation

Education

Bachelor's in life sciences

Master's or Doctorate preferred

Job description

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on advancing innovative therapies to improve quality of life for patients with cancer.

The Senior Director of Regulatory Affairs will lead global regulatory strategies and drive IND/CTA approvals, with oversight of BLA/MAA planning for oncology products. Reporting to senior leadership, you will coordinate across functions, manage regulatory submissions in multiple regions, and mentor regulatory team members.