Descripción de la oferta
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 global development milestones, aligned with organizational portfolio priorities and business objectives.ResponsibilitiesGlobal Regulatory Leadership (GRL): Regional LeadServe 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 & StrategyLead 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 DeliverablesProvide 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 & PrioritizationPartner 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 DevelopmentProvide 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 ResponsibilitiesSupport business development activities, due diligence, and regulatory risk assessments for external opportunities.QualificationsBachelor'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 SkillsDeep 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 requirementsAbility 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.
