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%
This is the pay for this position
Pay Transparency
$231,000-$285,000 USD
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
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