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
$275k - $280k
...medical breakthroughs. Position Description: Calico is seeking a Regulatory Director that will be responsible for, in collaboration with... ...develop effective CMC regulatory strategies Represent Regulatory Affairs on development teams and support development teams in...SuggestedFull time$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 package- ...Associate Director, Regulatory Affairs The Associate Director, Regulatory Affairs supports the development and execution of clinical regulatory strategies and regulatory development activities for assigned programs across regions. This role works closely with senior...SuggestedWork at office
Zai Lab (US) LLC
South San Francisco, CA4 days ago $210k - $260k
...Director, Regulatory Affairs Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results...SuggestedTemporary workLocal areaLyell Immunopharma
South San Francisco, CA2 days ago$265k - $285k
...****@*****.*** include: Provides regulatory leadership in support of the development, registration, and... ...with Clinical Development, Clinical Operations, Medical Affairs, CMC, and Quality to develop, coordinate, and implement global...Suggested- Associate Director, Regulatory Affairs (Onsite in S.SF - 3X/wk) Full-time Zai Lab Limited(NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based inChinaandthe United Statesfocused on bringing transformative medicines...Full timeWork at officeWorldwide
- ...s hybrid model requires this role to work in our office three days per week on average. Position Summary The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices...Work at officeLocal areaRemote workNight shift3 days per week
$189.7k - $237.1k
Position Summary: Director, Regulatory CMC. Develop and execute global regulatory CMC strategies supporting clinical development, marketing approvals... .... Primary Responsibilities: Manage CMC regulatory affairs for marketed products and compounds in development per US and...Worldwide- Enigma Search is seeking a seasoned Director of Regulatory Affairs to shape regulatory strategy for innovative programs. You will lead global submissions, interact with health authorities, and partner with executive leadership to align regulatory plans with corporate aims...
$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 specialty...For contractors- Responsibilities: Develop and implement global clinical & nonclinical regulatory strategies for immunology and inflammation indications;... ...strategies and operational plans. Represent Regulatory Affairs on assigned cross-functional development teams. Lead development...For contractors
- Position Title: Director, Regulatory Affairs (Strategy, Immunology and Inflammation) Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier...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$175k - $205k
...our mission and everything that we do on behalf of patients with cancer. Position Summary Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC Regulatory Affairs will lead and participate in regulatory activities...Temporary workCasual workLocal areaWorldwideFlexible hours$220k - $270k
Senior Director/ Director, CMC Regulatory Affairs ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by overcoming resistance in cancer. ORIC’s clinical stage product candidates include ORIC-944 and enozertinib. ORIC...Currently hiring- 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...
$190k - $210k
...making a profound impact, together - for our patients, for your career, and for what’s beyond.About the Role >>>Associate Director, Global Regulatory Affairs, ComplianceAs the Global Associate Director, Regulatory Affairs Compliance, reporting to the Senior Director, Global...Work at officeFlexible hours2 days per week$210.38k - $272.25k
...developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job DescriptionThe Director, CMC Regulatory Affairs - Combination Products and Device is responsible for setting and leading global CMC regulatory strategy for complex,...Full timeFor contractorsLocal area$302.01k - $390.83k
...together.Job DescriptionPOSITION OVERVIEW:The Executive Director, Head of Precision Medicine Regulatory is responsible for defining and leading enterprise-... ...closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with...Full timeFor contractorsWork at officeLocal areaFlexible hours- ORIC Pharmaceuticals Inc. in South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across oncology programs. You will collaborate with regulatory, quality, clinical, and manufacturing teams to develop regulatory strategies...
$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$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...Cytokinetics
San Francisco, CA3 days ago- ...Director, Regulatory CMC Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small molecule therapies... ...Primary Responsibilities Manages the CMC regulatory affairs activities for marketed products and compounds in...Work at officeRemote workWorldwideNight shift
ACADIA Pharmaceuticals
San Francisco, CA5 days ago $160k - $185k
...Job Description We are seeking a motivated Regulatory Affairs professional to join our team and help advance the clinical development of oncology products at ORIC. In this role, you will collaborate closely with colleagues across regulatory operations, quality, CMC...Odd jobH1bWork at officeOterra
South San Francisco, CA2 days ago$280k - $310k
...other individuals who embody our values: care, be real, get it done, and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the...Local area$275k - $280k
...pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.Position Description:The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and...$190k - $230k
Position: Associate Director, Regulatory Affairs Location: San Francisco (Hybrid - 2 days onsite) Reports To: Senior Director, Regulatory Affairs Compensation: $190-230k base salary + annual bonus + stock options About the company: With nearly half a billion in total funding...- ...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...
- Kardigan is looking for an Associate Director, Regulatory Strategy to support regulatory strategies and ensure high-quality deliverables. You... ...candidate has at least 6 years of experience in regulatory affairs, particularly within biotech or pharmaceuticals, and strong...
- 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...
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