Role Overview Planet Pharma’s clinical-stage biotechnology client is seeking an experienced Senior Director of Regulatory Affairs to serve as the company’s first internal Regulatory Affairs hire and senior regulatory leader for its clinical-stage oncology programs. Reporting to the Chief Medical Officer, the Senior Director will own and be accountable for global regulatory strategy and execution from Phase 1/2 development through registrational planning in the U.S., EU, UK, and support activities in Asia-Pacific, partnering closely with Clinical Development, Clinical Operations, CMC, Quality, and external regulatory partners. As the primary point of contact for health authorities and a senior regulatory advisor to cross-functional teams and leadership, the Senior Director will provide strategic guidance, hands-on execution, and proactive risk management, translating complex regulatory requirements into clear recommendations for program and company decisions. This is a hands-on leadership role based in Watertown, MA, requiring in-office presence at least 3 days per week, in a fast-paced, collaborative environment offering the opportunity to directly shape regulatory strategy, build the Regulatory Affairs function, and advance innovative therapies for patients. Key Responsibilities • Serve as the internal Regulatory Lead for clinical-stage oncology programs, developing and executing global regulatory strategy from Phase 1/2 development through registrational planning. • Lead regulatory strategy and execution for INDs, CTAs, amendments, and other submissions supporting new and ongoing clinical studies. • Ensure regulatory compliance and maintenance of active INDs and CTAs, including annual reports/DSURs, Investigator’s Brochure updates, and expedited safety reporting in partnership with Pharmacovigilance, and maintain inspection readiness. • Lead and negotiate health authority interactions with FDA, EU regulatory authorities, and MHRA, and other health authorities as programs expand (e.g., Asia-Pacific)–including strategy development, briefing materials, meeting preparation, and agency correspondence. • Provide strategic regulatory guidance on early clinical development, including positioning Phase 1 programs for successful Phase 2 development and expedited programs, designations, and approval pathways (e.g., Fast Track, Breakthrough Therapy, Orphan Drug, PRIME, Accelerated Approval). • Lead regulatory strategy for oncology-specific requirements, including dose optimization (FDA Project Optimus), pediatric plans (iPSP/PIP and RACE Act molecular-target assessments), and the evidentiary package needed for future registrational trials. • Serve as the accountable regulatory lead for all components of development programs, including any associated assays, biomarkers, diagnostics, or devices, as applicable. • Partner cross-functionally with Clinical Development, Clinical Operations, CMC, and Quality to embed regulatory strategy into development plans and program decisions. • Advise on clinical protocols, development plans, CMC changes and comparability, IND/IMPD content, product stability, and other issues arising during clinical development. • Anticipate regulatory risks and opportunities, lead resolution of critical regulatory issues, and develop practical, well-vetted mitigation strategies. • Monitor evolving U.S., EU, UK, and support activities in Asia-Pacific regulatory requirements and guidance (including FDA guidance on bispecific antibody development programs and oncology dose optimization) and translate the implications for development programs. • Manage and direct external regulatory consultants and vendors while building regulatory expertise and ownership in-house. • Establish and oversee practical regulatory processes, policies, and infrastructure appropriate for a growing clinical-stage biotech. • Represent Regulatory Affairs on cross-functional program teams and serve as a senior regulatory advisor to the leadership team, providing clear, actionable recommendations on strategic options, risks, and trade-offs. • Provide regulatory leadership for business development and partnerships, including regulatory due diligence, input into alliance governance, and coordination with partners’ regulatory teams. • Review regulatory content in investor, public, and SEC disclosures and support regulatory diligence for financings and other corporate transactions. • Build and scale Regulatory Affairs function as additional programs enter the clinic, including future team hiring, talent development, and line management. Qualifications/Experience • Bachelor’s degree in a life science required; advanced degree (PhD, PharmD, MD, or MS) strongly preferred. RAC certification a plus. • 12+ years of Regulatory Affairs experience in biotechnology or pharmaceutical drug development, with demonstrated progression into senior regulatory strategy and leadership roles. • Strong experience supporting Phase 1 and Phase 2 oncology drug development; experience with T cell engagers, bispecific antibodies, or other immuno-oncology biologics strongly preferred. • Experience with late-stage development planning, including End-of-Phase 2 meetings, registrational trial design, expedited programs, and Accelerated Approval with confirmatory trials (preferred); BLA/MAA experience a plus. • Familiarity with regulatory requirements for biomarkers, assays, or in vitro diagnostics used in clinical development (preferred). • Significant experience with U.S. INDs and direct FDA interactions. • Strong experience with EU clinical trial submissions and CTIS; UK/MHRA and Asia-Pacific (e.g., PMDA) regulatory experience preferred. • Proven track record leading and negotiating health authority interactions, including preparation of briefing materials, meeting strategy, and regulatory correspondence. • Experience working cross-functionally with Clinical Development, Clinical Operations, CMC, and Quality. • Working knowledge of CMC regulatory considerations during early clinical development. • Experience operating in a small or mid-sized biotechnology environment (preferred). • Experience in a public company environment, including review of regulatory disclosures and support of financing or partnering diligence (preferred). • Experience managing external regulatory consultants, CROs, or other regulatory service providers, including regulatory operations and eCTD publishing vendors. • Experience building or scaling a Regulatory Affairs function, including people leadership and talent development (preferred). • Excellent communication skills and executive presence, with the ability to influence senior leadership and collaborate effectively across teams; highly organized with strong problem-solving, critical thinking, and prioritization skills.