Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology in Abbeyville, Colorado at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology based in United States.

The Senior Director will provide global regulatory leadership for complex oncology programs across late-stage development, registration, and lifecycle management. This high-impact role will shape regulatory strategies designed to achieve global approvals and optimize product labeling across regions. You will lead Global Regulatory Teams and serve as a senior regulatory voice within cross-functional development and commercialization teams. The position requires strong scientific judgment, strategic thinking, and the ability to navigate complex global regulatory environments. You will lead major regulatory submissions and agency interactions while identifying risks, opportunities, and innovative regulatory pathways. This is a highly collaborative role with significant influence across global functions, external partners, and regulatory authorities. The successful leader will help advance innovative oncology therapies while building strong teams and delivering sustainable regulatory success.

• Lead Global Regulatory Teams for one or more high-complexity oncology programs, particularly assets in late-stage development, with multiple indications or significant global regulatory complexity.
• Develop and execute comprehensive global regulatory strategies that support product development, worldwide registration, target labeling, and long-term lifecycle management.
• Represent Global Regulatory Affairs on product teams and commercialization governance bodies, providing strategic direction and influencing decisions to achieve regulatory objectives.
• Independently develop Global Regulatory Strategic Plans and provide regulatory input into broader product strategies, incorporating input from cross-functional regulatory stakeholders.
• Identify, communicate, and mitigate regulatory risks, uncertainties, and potential obstacles across development and commercialization programs.
• Provide regulatory direction for development of core data sheets and ensure commercial objectives are appropriately balanced with available scientific evidence, regulatory guidance, and relevant precedent.
• Lead planning and execution of global regulatory submissions, including clinical trial applications, original marketing applications, label extensions, and other major filings.
• Ensure regulatory submission documents and global product communications remain consistent, accurate, evidence-based, and aligned with regulatory strategy.
• Monitor evolving global regulations, guidance, regulatory environments, and agency expectations, assessing their potential impact on development and registration strategies.
• Evaluate and incorporate regulatory mechanisms that may optimize development and approval pathways, including expedited development programs, orphan designations, accelerated or conditional approvals, compassionate use, and pediatric plans.
• Lead formal and informal interactions with regulatory agencies and establish strategies for high-impact agency meetings that may influence global product development or registration.
• Clearly communicate regulatory strategies, risks, mitigation plans, contingencies, and potential outcomes to senior stakeholders and cross-functional teams.
• Represent Regulatory Affairs on external partnership teams at the product level and ensure regulatory priorities are appropriately integrated into collaborative programs.
• Lead regulatory process improvement initiatives and identify opportunities to strengthen organizational effectiveness and regulatory execution.
• Build, lead, and develop high-performing regulatory teams, fostering collaboration, accountability, scientific rigor, and effective decision-making.

• Doctorate degree with at least 5 years of regulatory experience in biotechnology or a scientific discipline; or a Master’s degree with at least 9 years of relevant regulatory experience; or a Bachelor’s degree with at least 11 years of relevant regulatory experience.
• At least 5 years of direct people management and/or leadership experience overseeing teams, projects, programs, or resource allocation. This leadership experience may overlap with the required technical experience.
• Demonstrated experience leading regulatory strategy for highly complex programs in late-stage development.
• Contemporary oncology regulatory experience is strongly preferred.
• Proven experience leading regulatory teams through the submission and approval of an original marketing application and/or major supplemental application for a new indication.
• Strong understanding of global regulatory requirements, scientific and clinical development, regulatory precedents, and evolving agency expectations.
• Demonstrated ability to develop and communicate comprehensive regulatory strategies across global development and commercialization programs.
• Strong scientific and clinical acumen, with the ability to understand complex data and communicate implications clearly to technical and non-technical stakeholders.
• Exceptional written and verbal communication skills, including the ability to communicate regulatory risks, recommendations, and strategic options concisely to senior leadership.
• Strong leadership, team-building, negotiation, conflict-resolution, and stakeholder-management capabilities.
• Ability to anticipate strategic issues, manage uncertainty, evaluate complex trade-offs, and develop practical mitigation strategies.
• Proven ability to influence cross-functional teams and senior stakeholders while navigating complex organizational environments.
• Strong planning, prioritization, organization, and decision-making skills, with the ability to manage multiple high-priority activities simultaneously.
• Cultural awareness and sensitivity, with the ability to collaborate effectively across global teams and regulatory environments.
• Demonstrated ability to operate effectively in ambiguous and rapidly evolving situations while maintaining sound judgment and strategic focus.

• Annual U.S. base salary range of $215,204.70–$291,159.30, with actual compensation determined by relevant skills, experience, qualifications, and other applicable factors.
• Comprehensive health and welfare benefits for eligible employees and dependents.
• Medical, dental, and vision coverage.
• Retirement and savings plan with generous company contributions.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus opportunity.
• Stock-based long-term incentives.
• Award-winning paid time-off programs.
• Flexible work models where applicable.
• Career development and professional growth opportunities.
• A collaborative, science-driven environment focused on advancing innovative treatments for serious diseases.
• Inclusive workplace culture that values diverse perspectives, ethical leadership, scientific excellence, and collaboration.
• Reasonable accommodations available for qualified individuals with disabilities throughout the employment and interview process.
• Sponsorship may be available depending on circumstances and is not guaranteed.