Senior Director, Regulatory Affairs

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

📋 Description

• Design and implement worldwide strategies to obtain IND/CTA approvals for studies.

• Provide regulatory guidance for the planning and execution of global marketing applications (BLA/MAA) related to oncology products.

• Direct global regulatory strategies for designated products and indications throughout all development phases.

• Assist Regulatory Affairs in development collaborations and partnerships, acting as the primary regulatory contact at Summit for partner IND/CTA study requirements.

• Broaden therapeutic-area expertise and ensure the strategic messaging and content of global regulatory submissions.

• Create tumor landscape evaluations to inform the evolving development strategy.

• Counsel management and cross-functional team members on pertinent laws, regulations, guidelines, and standards.

• Lead Labeling Regulatory Teams for specific products or indications as necessary.

• Ensure that corporate objectives are achieved for assigned projects.

• Coach and mentor fellow regulatory team members.

• Potentially oversee direct reports and participate in the performance management of other Regulatory Affairs team members.

• Engage in and assume leadership roles in professional associations, industry, and trade groups as appropriate.

• Adhere to budgetary 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 10+ years of experience in pharmaceutical regulatory activities.

• Experience as the lead regulatory product strategist in two or more significant regions beyond the US, such as the EU, Japan, or China.

• Experience and direct involvement in marketing/license applications, including BLA, NDA, and MAA.

• Drug development experience in both the US and EU.

• Minimum of 5+ years of demonstrated experience in a strategic leadership position.

• Strong project management abilities.

• Experience working in a cross-functional setting with multiple stakeholders while influencing cross-functional teams.

• 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.

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

• Willingness to travel up to approximately 5%.

🏝️ Benefits

• Bonus, stock options, benefits, and/or other applicable variable compensation may be included in the overall compensation package.

• Approximately 5% travel.