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

📌 Senior Director Regulatory Affairs (Lugo)
🏢 Discover International
📍 Lugo