Global Regulatory Director, Oncology | IND/CTA & BLA Lead

Regulatory Toolkit; Miami (FL); On-site; USD 203,000 - 253,000; Full time

Job summary

Summit Therapeutics Inc. is seeking a Senior Director of Regulatory Affairs to develop and implement global IND/CTA strategies and lead preparations for global marketing applications (BLA/MAA) in oncology.

The role requires extensive regulatory leadership, cross-functional collaboration, and experience across US and at least two major regions (EU, Japan, or China). Travel up to 5% is possible.

Qualifications

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• 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 (e.g., EU, Japan, or China).
• Experience and direct involvement with marketing/license applications (e.g., BLA, NDA, MAA).
• Requires drug development experience in US & EU.

Responsibilities

• Leads global regulatory strategies for assigned products/indications through all phases of development.
• May support Regulatory Affairs in development collaborations and be the primary contact for Summit regulatory for partner IND/CTA requirements.
• Develops tumor landscape assessments to inform evolving development strategy.
• Advises management on effects of laws, regulations, guidelines, and standards.
• May lead the Labeling Regulatory Team for given product(s)/indication(s).
• Ensures corporate goals are met for assigned projects and expands TA knowledge with coaching of other RA members.

Skills

Regulatory leadership

Cross-functional leadership

Project management

Communication

Negotiation

Education

Bachelor's degree in life sciences

Masters or Doctorate preferred

Job description

Summit Therapeutics Inc. is seeking a Senior Director of Regulatory Affairs to develop and implement global IND/CTA strategies and lead preparations for global marketing applications (BLA/MAA) in oncology.

The role requires extensive regulatory leadership, cross-functional collaboration, and experience across US and at least two major regions (EU, Japan, or China). Travel up to 5% is possible.