Executive Director – Regulatory Affairs, Global

This is a fully remote position, open to applicants in United States.

📋 Description

• Operate autonomously to spearhead global regulatory strategies for designated products/indications throughout all development phases, encompassing regulatory approvals, product launches, and post-marketing initiatives, with minimal oversight.

• Represent Regulatory Affairs concerning development collaborations and/or partnerships, including leading due diligence as necessary to support business development activities.

• For newly assigned indications, take the lead in regulatory efforts in collaboration with colleagues from clinical, biostatistics, commercial, medical affairs, clinical pharmacology, safety, and other functions. Expected to contribute content for potential study synopses and relevant global regulatory briefing documents.

• Continuously enhance therapeutic area knowledge and ensure the strategic messaging and content of global regulatory submissions, including the development of tumor landscape assessments to inform evolving development strategies.

• Counsel management and cross-functional team members on the implications of current or proposed relevant laws, regulations, guidelines, and standards.

• Serve as a key internal leader and advocate for regulatory policy and strategy for assigned products.

• Oversee the regulatory team in preparing and maintaining risk assessment and mitigation strategies for assigned products.

• Direct the labeling strategy for specified product(s)/indication(s), supporting initial license applications through post-marketing efforts.

• Exhibit a strong understanding of drug development and demonstrate leadership behaviors appropriate for the position's level.

• Responsible for ensuring that corporate objectives are achieved regarding assigned projects.

• Based on experience and scientific expertise, enhance therapeutic area knowledge; provide coaching and mentoring to other regulatory team members and colleagues across departments.

• Will have direct reports and will contribute to the performance management of other Regulatory Affairs team members.

• May further the organization's objectives by participating in and taking leadership roles within professional associations, industries, and trade groups as applicable.

• Adhere to budget allocations.

⛳️ Requirements

• Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or a related field; a Master’s or Doctorate is preferred.

• At least 15+ years of experience in pharmaceutical/biotech regulatory activities, including experience as the lead regulatory product strategist in two or more major regions beyond the US, such as EU, Japan, or China.

• Expected to have substantial experience with direct involvement and leadership related to marketing/license applications (e.g., BLA, NDA, MAA), and given the late-stage nature of Summit’s clinical development programs, experience in supporting regulatory approvals and necessary activities for product launch and post-marketing efforts.

• Extensive experience managing partnerships and collaborations directly.

• Requires drug development experience in establishing global regulatory strategy in alignment with cross-functional peers to support the company’s corporate goals.

• A minimum of 10+ years of demonstrated experience in a strategic leadership role, with strong project management capabilities.

• Experience engaging with major government regulatory authorities.

• Excellent communication and proactive negotiation skills.

• Ability to communicate effectively and convey complex ideas in a clear and understandable manner.

• Capability to thrive in a fast-paced, demanding, and collaborative environment.

• Willingness to travel up to approximately 5%.

🏝️ Benefits

• Actual compensation packages are determined by various factors unique to each candidate, including, but not limited to, skill set, depth of experience, certifications, and specific work location. Compensation may differ in other locations due to variations in labor costs. The total compensation package for this position may also include bonuses, stock options, benefits, and/or other applicable variable compensation.