Director of Regulatory Policy Projects

The Senior Director, Regulatory Affairs is responsible for leading regulatory strategy and execution for assigned development programs, with a primary focus on oncology and broader disease areas as needed. This role will serve as the Global Regulatory Lead for designated assets and will be accountable for end-to-end regulatory leadership from early development through registration and lifecycle management, including IND/CTA, Health Authority meetings, Scientific Advice, Marketing Authorization Applications, and post-approval commitments.

About the Role

The Senior Director will provide strategic regulatory leadership to cross-functional teams to ensure timely and successful delivery of global development milestones, aligned with organizational portfolio priorities and business objectives.

Responsibilities

Global Regulatory Leadership (GRL): Regional Lead

• Serve as global regulatory lead for assigned region/assets, owning the global regulatory strategy with primary accountability for key regulatory pathways.
• Define and drive regulatory strategy for development, registration, labeling, and lifecycle management for oncology and select non-oncology programs.
• Lead cross-functional governance and ensure alignment of regulatory strategy with Clinical, CMC (Chemistry, Manufacturing, and Controls), Nonclinical, Safety, Biometrics, Medical, and Commercial stakeholders.

Health Authority Engagement & Strategy

• Lead planning and execution of Health Authority interactions (Scientific Advice, pediatric/post-authorization strategy where applicable, MAA pre-submission activities).
• Act as primary regulatory liaison for assigned programs with relevant Health Authorities and support interactions with other key agencies as needed.
• Translate evolving regulatory expectations into clear program-level plans and decision points.

Major Submissions & Regulatory Deliverables

• Provide strategic oversight and hands-on leadership for: IND/CTA, MAA submissions, Responses to Information Requests, Letters of Questions/Letters of Intent, deficiency letters, and Advisory Committee preparedness (as needed).
• Ensure consistency and quality of regulatory content across Common Technical Document (CTD) modules, including strategy framing, risk mitigation, and benefit-risk positioning.

Portfolio Leadership & Prioritization

• Partner with leadership to prioritize regulatory workstreams across pipeline based on value, timeline criticality, and probability of success.
• Anticipate regulatory risks early (clinical design, endpoints, comparators, CMC readiness, safety signals, companion diagnostics) and drive mitigation plans.

Leadership & Team Development

• Provide leadership, coaching, and development support to regulatory team members.
• Foster a culture of high integrity, accountability, transparency, and collaboration, ensuring strong partnership across global functions.
• Support process improvements, templates, and scalable best practices to improve regulatory execution quality and speed.

Other Responsibilities

• Support business development activities, due diligence, and regulatory risk assessments for external opportunities.

Qualifications

• Bachelor's degree required; Master's, PharmD, or PhD strongly preferred in life sciences or related discipline.
• 12+ years of regulatory affairs experience in biotech/pharma (or equivalent combination).
• Demonstrated experience as a regulatory strategy lead for oncology or non-oncology development programs across phases.
• Proven track record supporting major submissions and/or approvals.
• Experience leading Health Authority interactions and strategy strongly preferred.

Required Skills

• Deep knowledge of regulatory requirements from key Health Authorities, including ICH guidelines.
• Strong understanding of drug development strategy, including: Endpoint selection and regulatory acceptability, Biomarker/precision medicine approaches.
• Accelerated/conditional pathways and confirmatory requirements
• Ability to lead complex programs in a fast-paced environment with strong judgment and prioritization.
• Excellent communication and influencing skills across senior stakeholders.
• Strong capability in negotiation with Health Authorities.
• Demonstrated ability to work effectively in global and cross-cultural environments.
• High integrity, strong ethics, and commitment to compliance.