Director, Regulatory Affairs
Enigma Search
About the job Director, Regulatory Affairs Are you a seasoned Regulatory Affairs professional ready to make a significant impact on human health? We are seeking a strategic and driven Director of Regulatory Affairs to join a pioneering research and development company focused on extending healthy lifespan. This is an exceptional opportunity to play a pivotal role in developing and implementing innovative regulatory strategies for groundbreaking programs. You will collaborate with cross-functional teams and external partners, driving regulatory success from IND-enabling studies through clinical proof-of-concept and beyond. Your Impact: Develop and execute global regulatory strategies for assigned programs, including first-in-class therapies and programs with external partnerships. Lead interactions with global health authorities, preparing briefing packages and ensuring clear communication. Collaborate with executive leadership to define regulatory strategies aligned with the company's mission. Oversee the preparation and submission of regulatory applications, ensuring accuracy and timeliness. Develop effective CMC regulatory strategies in collaboration with Technical Operations. Provide strategic regulatory input to development teams, protocols, reports, and other critical documents. Stay ahead of global regulatory changes, communicating updates and developing proactive strategies. Collaborate with cross-functional teams and external consultants. What You Bring: Masters degree in a life science discipline (PhD preferred). Minimum of 10 years of regulatory affairs experience in industry, academia, or clinical research, with experience in rare disease development and/or novel endpoints. Proven track record of developing regulatory submissions, including experience with major approvals (NDA, BLA, MAA, etc.). Strong knowledge of global regulations (FDA, EMA, etc.). Experience with mechanisms to expedite agency interactions. Advanced skills in creating and assessing regulatory proposals and leading health authority interactions. Excellent communication and influencing skills. Self-motivated, strategic thinker with strong problem-solving skills. Exceptional organizational and prioritization skills. Ability to thrive in a fast-paced, collaborative, start-up environment. Must be willing to work onsite at least four days per week. #J-18808-Ljbffr Enigma Search
$180k - $241k
...Company has a global team of approximately 2000 employees. Job Description Primary Function: The Associate Director, Regulatory Affairs supports the development and execution of clinical regulatory strategies and regulatory development activities for...SuggestedFull timeRemote workWorldwideRelocation packageZai Lab (US) LLC
South San Francisco, CA13 days ago- ...Role Associate Director, Regulatory Affairs, based in South San Francisco, supporting clinical regulatory strategies and submissions for biopharmaceutical programs. Responsibilities lead regulatory strategy development prepare INDs and amendments coordinate...Suggested
Scorpion Therapeutics
South San Francisco, CA5 days ago $225k - $262.5k
...Director, Regulatory AffairsSkip to main content# CareersDirector, Regulatory Affairs page is loaded## Director, Regulatory AffairsApplylocations: South San Francisco, Californiatime type: Full timeposted on: Posted 29 Days Agojob requisition id: R468Cytokinetics is a...SuggestedFor contractorsCytokinetics
South San Francisco, CA2 days ago$120.2k - $223.2k
The PositionCommercial Regulatory Affairs (CORA) is part of the Global Product and Access Legal (GPAL) organization that interprets the needs... ...in the Global Legal Pharma Department.Associate Program Directors of Commercial Medical Legal Regulatory Review Committees (CMLRs...SuggestedFull timeWork experience placementLocal areaWorldwideRelocation packageGenentech
South San Francisco, CAa month ago$275k - $280k
Position Description Calico is seeking a Regulatory Director that will be responsible for, in collaboration with development partners as applicable... ...effective CMC regulatory strategies Represent Regulatory Affairs on development teams and support development teams in...SuggestedFull time$210k - $260k
...mission's urgency. This role can be based out of either our Seattle, WA or South San Francisco, CA offices. TheDirector of Regulatory Affairs/Global Regulatory Lead (GRL)will be focusing on the development of cutting-edge CAR-T cell therapies in oncology. As the GRL...Temporary workLocal area$220k - $254k
Director, Regulatory Affairs (Strategy, I&I) Brisbane, California, United States Director, Regulatory Affairs - Strategy, Autoimmune Disease (AID) Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization...For contractorsWork at office$232k - $274k
Job Summary: Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team. The successful candidate will be a core member of the Regulatory team working in close collaboration with the...For contractorsWorldwide- Lyell Immunopharma is seeking a Director of Regulatory Affairs/Global Regulatory Lead to define, develop, and execute global regulatory strategies for CAR-T programs from early development through licensure and lifecycle management. You will serve as the primary regulatory...
$230k - $270k
...and at greater scale to more patients. About the role: Allogene Therapeutics is seeking a highly motivated Senior Director, CMC Regulatory Affairs in the Global Regulatory Affairs and Clinical Quality group to support products under development and lead CMC product...Full timeContract workInternshipLocal areaRemote work2 days per weekAllogene Therapeutics
South San Francisco, CA4 days ago$263.88k - $307.86k
## Senior Director, Regulatory Affairs REMS ProgramApplylocations: South San Francisco, Californiatime type: Full timeposted on: Posted 2 Days Agojob requisition id: R482Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years...For contractors- AbbVie seeks a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance and deployment of data standards across clinical trials, ensuring conformance to CDISC and industry best practices including SDTM and ADaM. You will lead cross-functional teams to ...
$200.7k - $234.15k
...a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. The Associate Director, Regulatory Affairs reports to the Executive Director of Regulatory Affairs and performs hands‑on regulatory activities across development stages...- ...Executive Director, Regulatory Affairs About the Company Esteemed company developing medicines for inflammatory & autoimmune diseases Industry Biotechnology Type Privately Held, VC-backed Founded 2018 Employees 51-200 Funding $101-$200 million...
- AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for complex products. You will collaborate with R&D, Operations and Global Regulatory teams to enable first-pass approvals and ensure compliant content for INDs...
$337.5k - $393.8k
...strategic leader for the role of Executive Director, U.S. Healthcare Compliance. In support... ...as we scale our commercial and medical affairs operations and patient support programs,... ...and state laws and regulations and self-regulatory codes and guidelines applicable to the...- Director of Regulatory Affairs | Job Description About ZBiotics At ZBiotics, we make genetically engineered probiotics that improve daily life. As a group of motivated, yet down-to-earth people, we are fueled by two things: a love for science and a commitment to being...Day shift
- Marea Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategy for biological products in the US and globally. You will work with cross‑functional teams to align CMC plans with development milestones...
- Calico Life Sciences is looking for a Regulatory Director in South San Francisco to develop and implement innovative regulatory strategies, ensuring compliance with health authority guidelines. The role requires collaboration with various teams, overseeing regulatory submissions...
$263.88k - $307.86k
Cytokinetics is seeking a Senior Director for Regulatory Affairs in South San Francisco. This role involves leading regulatory strategies related to Risk Evaluation and Mitigation Strategies (REMS), ensuring compliance, and managing cross-functional teams. The ideal candidate...- Sentibio in South San Francisco seeks a regulatory affairs leader to drive CMC strategies for a complex cell therapy program. You will shape global regulatory CMC plans, coordinate type B/C/D meetings, and ensure alignment with agency expectations across the organization...
- Nurix Therapeutics, Inc. invites an experienced Director/Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team. You will develop and execute the global regulatory strategy, guide high-quality submissions, and work with cross...
- Vaxart, Inc. is seeking a Senior Director, Quality Assurance to lead the QA strategy for clinical‑stage oral vaccine programs at the... ...supply of investigational products. The role partners with CMC, Regulatory, Quality Control, Clinical Supply and external CDMOs to...
- Marea Therapeutics, Inc. is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies... .... This role reports to the Executive Director of Regulatory Affairs and requires strong strategic thinking and hands-on execution...Full time
- Kardigan seeks a Senior Director, CMC Regulatory to lead the development and execution of CMC regulatory strategies driving global submissions... ...candidate has a scientific degree with 10+ years in regulatory affairs, strong FDA/EMA/ICH knowledge, and experience with IND/IMPD...
- Zai Lab Limited seeks a senior CMC regulatory leader to drive global regulatory strategy for both small molecules and biologics from its South San Francisco office. You will oversee IND/CTA and NDA/BLA submissions, coordinate with health authorities, and guide cross-functional...Work at office
- Kardigan, Inc. seeks a Senior Director, CMC Regulatory to lead regulatory activities for late-stage cardiovascular assets. You will define and... ...programs. The ideal candidate has 10+ years in CMC regulatory affairs, strong FDA/EMA knowledge, and a track record of global...
- Nurix Therapeutics, based in Brisbane, CA, seeks a Director, Regulatory Affairs (Strategy, I&I) to lead global regulatory strategy for immunology and inflammation programs. The role requires coordinating with internal teams and Health Authorities to enable timely regulatory...
- Marea Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to shape regulatory strategies for manufacturing... .... The role reports to the Executive Director of Regulatory Affairs and will own CMC submissions and alignment with Tech Ops. On...Work at office2 days per week
- Kardigan in Princeton, NJ is seeking a Senior Director, Clinical Pharmacology to lead strategies across cardiovascular development and regulatory interactions with FDA and global health... ...Development, Biometrics, Regulatory Affairs, and Medical Writing to ensure...
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