Executive Director, Regulatory Affairs – Global Regulatory Leader

Overview of Role:

The Executive Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications (BLA/MAA) for product(s) in the oncology therapeutic area.

Role and Responsibilities:

• Act independently to lead global regulatory strategies for assigned products/indications through all phases of development to include regulatory approvals/product launches, and post-marketing efforts, with little to no oversight.
• Will represent Regulatory Affairs as relates to development collaborations and/or partnerships, to include leading due diligence as required supporting BD activities
• For new indications assigned, will lead effort on behalf of regulatory cross-functionally with colleagues from clinical, biostatistics, commercial, medical affairs, clinical pharmacology, safety, and others. Expected to provide material (content) input into potential study synopses and corresponding global regulatory briefing documents.
• Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers, to include development of tumor landscape assessment to inform evolving development strategy.
• Advises management and cross-functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards, etc.
• Key internal leader and driver of regulatory policy and strategy for assigned products
• Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products
• Lead labeling strategy for given product(s)/indication(s), in support of initial license applications through post-marketing
• Demonstrates excellent understanding of drug development and leadership behaviors consistent with the 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 and extra-departmental colleagues
• Will 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

Experience, Education and Specialized Knowledge and Skills:

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject; Masters or Doctorate preferred.
• Minimum of 15+ years of experience in pharmaceutical/biotech regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Japan, or China.

• Expected to have significant experience with direct involvement/leadership as relates to marketing/license applications (e.g., BLA, NDA, MAA), and given late-stage nature of Summit’s clinical development program(s), experience supporting regulatory approvals and required activities in support of product launch and post marketing efforts.

• Significant experience dealing with partners/collaborations directly
• Requires drug development experience setting global regulatory strategy in alignment with cross functional peers to support company’s corporate goals.
• Minimum of 10+ years of proven experience in a strategic leadership role with strong project management skills
• 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%