Director, Regulatory Affairs

Position Summary The Director, Clinical Regulatory Affairs serves as a senior regulatory leader responsible for shaping and executing the global clinical regulatory strategy across Nektar’s development portfolio. This role oversees end‑to‑end planning and delivery of global clinical submissions, leads the creation and release of core regulatory dossiers, drives country‑level customization strategies, and ensures high‑quality responses to regulatory RFIs to support timely trial startup and advancement. The Director, Clinical Regulatory Affairs partners closely with Clinical Operations, Clinical Development, Safety, and CMC leadership and serves as a key point of contact for global regulatory agencies on clinical matters. Key Responsibilities Strategic Leadership & Regulatory Planning Define and lead the company’s global clinical regulatory strategy, ensuring alignment across programs, territories, and development milestones. Serve as the senior regulatory advisor to program teams, helping shape clinical development plans, scientific strategies, and geographic expansion. Stay abreast of the regulatory landscape and regulatory requirements. Anticipate regulatory challenges, conduct strategic risk assessments, and propose clear, data‑driven mitigation strategies. Represent Regulatory Affairs leadership in governance forums, providing decision‑making support and regulatory insights to senior management. Oversee the planning, authorship, review, and delivery of all major clinical regulatory submissions, including: New Drug Application (NDA) IND/CTA filings and amendments Health authority pre‑submission and post‑submission packages DSURs, Annual Reports, SUSAR submissions Protocols, IBs, and related clinical documentation Lead cross‑functional submission teams with CROs, ensuring clarity of roles, timelines, and quality expectations. Establish and continuously optimize submission processes, tools, templates, and governance standards. Core Dossier Management & Country Customization Direct the development, release, and lifecycle management of global core clinical dossiers, ensuring scientific rigor, regulatory compliance, and internal alignment. Drive strategies for efficient global rollout, including harmonization across regions and scalable dossier architecture. Provide executive‑level guidance to regional teams on country‑specific customization, ensuring adherence to local regulations, formats, language requirements, and health authority expectations. Approve localized submissions for strategic consistency and regulatory integrity. Regulatory RFIs & Agency Interactions Oversee the development of robust, scientifically sound, and timely Requests for Information (RFI) responses, ensuring alignment with overall regulatory and clinical strategy. Lead preparation for and participation in key regulatory interactions (FDA, EMA, MHRA, PMDA, and other agencies). Clinical Operations Partnership & Trial Execution Partner with Clinical Operations leadership to ensure regulatory considerations are fully integrated into trial startup, conduct, and closeout. Guide regional feasibility and startup planning from a regulatory perspective, including country prioritization and risk management. Oversee vendor and CRO performance related to regulatory responsibilities. Ensure organization‑wide inspection readiness and provide senior oversight during audits and regulatory inspections. Qualifications Required Bachelor’s degree in life sciences or related field; advanced degree strongly preferred. 12+ years of regulatory affairs experience in biotech/pharma, with substantial leadership experience supporting global clinical programs. Demonstrated success leading global IND/CTA submissions, dossier management, and regulatory interactions. Expertise in crafting high‑quality RFI responses and managing complex regulatory communications. Deep knowledge of ICH GCP, global clinical trial regulations, and regional requirements (FDA, EMA, MHRA, NMPA, PMDA, etc.). Proven experience influencing cross‑functional leaders and driving alignment on regulatory strategy. Outstanding communication, leadership, and organizational skills. Preferred Experience with biologics, gene therapies, cell therapies, or other advanced modalities. Prior responsibility for global rollout of core clinical dossiers or large‑scale clinical submission programs. RAC certification or equivalent credential. Experience in fast‑paced or emerging biotech environments. Additional Information Nektar currently anticipates the base salary for the Director, Regulatory Affairs to range from $240,000 to $275,000 for candidates in the Bay Area and will depend, in part, on successful candidate’s location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data. Benefits Health Insurance (Medical/Dental/Vision) Disability Insurance Holiday Pay Paid Time Off (PTO) 401(k) Match Employee Stock Purchase Plan Wellness Programs Parental Leave Benefits (in accordance with the terms of applicable plans) We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance. #J-18808-Ljbffr