Director, REMS Regulatory Strategy & Compliance
$263.88k - $307.86kCytokinetics
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 has over 10 years of experience in the pharmaceutical sector, with a strong background in REMS operations and strategy. The position offers a competitive salary range of $263,880 to $307,860 per year. #J-18808-Ljbffr Cytokinetics
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Director, REMS Regulatory Strategy & Compliance in South San Francisco, CA vacancy
$263.88k - $307.86k
## Senior Director, Regulatory Affairs REMS ProgramApplylocations: South San Francisco, Californiatime type... ...responsible for leading regulatory strategy and execution related to Risk Evaluation... ...(REMS) and providing regulatory compliance oversight for REMS.# **Responsibilities...SuggestedFor contractors$170k - $230k
Position Title: Associate Director, Regulatory Strategy Reports To: Executive Director, Regulatory Department: Regulatory Location: South San... ...DSURs) to ensure alignment with regulatory strategy and compliance with applicable regulations and guidance Track submission...Suggested- 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...Suggested
- Responsibilities: Develop and implement global clinical & nonclinical regulatory strategies for immunology and inflammation indications; identify risks and mitigation strategies. Collaborate with Regulatory leadership, development team leaders, cross-functional partners...SuggestedFor contractors
- ORIC Pharmaceuticals, Inc. is seeking a Senior Director/Director, CMC Regulatory Affairs to lead global CMC regulatory strategies and documentation for oncology programs. Based in South San Francisco, you will partner with Regulatory Affairs, Quality, and Clinical teams...Suggested
- Maze Therapeutics is seeking a senior regulatory medical writer to lead the function across development programs. You will develop high... ...Clinical Development, Biostatistics, and Safety to align on program strategy and data interpretation while driving standards and efficiency...
- Corvus Pharmaceuticals, Inc. in South San Francisco, CA, is seeking a Director of Regulatory Affairs CMC to lead global regulatory strategies for small molecule programs from IND/CTA through NDA/MAA and lifecycle management. Reporting to the VP of Regulatory Affairs, the...
$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- Marea Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to shape regulatory strategies for manufacturing across the US and global markets. The role reports to the Executive Director of Regulatory Affairs and will own CMC...Work at office2 days per week
- Marea Therapeutics, Inc. is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for US and global manufacturing programs. This role reports to the Executive Director of Regulatory Affairs and requires...Full time
- Nurix Therapeutics, Inc. is seeking a Director/ Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to develop and execute global regulatory strategy and lead high-quality submissions. You will partner with SVP Regulatory Affairs and cross-functional...
- Kardigan seeks a Senior Director, CMC Regulatory to lead the development and execution of CMC regulatory strategies driving global submissions and interactions with health authorities. This role reports to the Head of CMC Regulatory and is based in South San Francisco,...
- 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
- 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...
- 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...
- 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...
$103k - $138k
...Responsibilities JOB PURPOSEThe Manager, Environmental Compliance & Strategy, EPC is responsible for ensuring environmental compliance and... ...with internal project teams, consultants, contractors, regulatory authorities, and local interest groups to ensure Pattern’s...Full timeTemporary workFor contractorsWork experience placementLocal area- ...leading biotechnology company in South San Francisco seeks a Director of Clinical Regulatory to oversee multiple clinical drug candidates and drive... ..., leading project teams, and developing regulatory strategies. An ideal candidate will have at least 10 years of experience...
$275k - $280k
...breakthroughs. Position Description: Calico is seeking a Regulatory Director that will be responsible for, in collaboration... ...and implementing innovative regulatory strategies to support development programs, in compliance with health authority guidelines and regulations...Full time- Zai Lab is seeking a global CMC regulatory leader to head regulatory strategy for small molecules and biologics across all development stages. You will... ...and manage end-to-end dossier preparation, ensuring compliance and scientific rigor. You will lead a team of CMC professionals...Worldwide
- VetJobs in Princeton, New Jersey, is seeking a regulatory affairs leader to develop and manage Global and US regulatory activities for... ...regulatory issues in plans. You will formulate US regulatory strategy, lead global submissions, and provide input on target product...
- Nurix Therapeutics, Inc. is seeking a Sr. Director, Head of Regulatory & Medical Writing to lead the regulatory writing group and guide the preparation of high-quality regulatory documents for clinical trials and submissions. You will collaborate with Clinical Science,...
- ACADIA Pharmaceuticals Inc. seeks a Director, Regulatory CMC to lead global regulatory CMC strategies for small molecule programs from development through commercialization. You will advance development, regulatory submissions, and lifecycle management across key regions...
- Scorpion Therapeutics is seeking a Director, Regulatory CMC to lead global CMC strategies across clinical development, approvals, and lifecycle management. You... ...teams, interface with agencies, and ensure compliance with regulatory requirements across regions. The role...
- Cytokinetics is seeking a Director, US Promotional Medical Review, Cardiovascular to ensure medical accuracy and regulatory compliance across US promotional and non-promotional materials... ..., and influence cross-functional strategy while ensuring #J-18808-Ljbffr Cytokinetics...
$245k - $302k
...Therapeutics, Inc. is seeking a Senior Director of Medical Writing in South San Francisco... ...candidate will provide leadership on regulatory documents and oversee a team, requiring... ...have a strong commitment to integrity in compliance with regulations. #J-18808-Ljbffr...$258k - $320k
...Primary Function: Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological... ...ensuring scientific soundness, data integrity, and regulatory compliance across all product modalities. Develop and implement comprehensive...Work at officeWorldwideRelocation packageZai Lab (US) LLC
South San Francisco, CA6 days ago$245k - $285k
...responsible for leading and managing the regulatory affairs within CMC function. This... ...developing and leading regulatory CMC strategies and activities for a complex cell therapy... ...the global regulatory phase-appropriate compliance of gene and cell therapy pipeline of products...Contract workSenti Biosciences
South San Francisco, CA14 days ago- ...Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible... ...Global Regulatory Lead (GRL), Associate Director, or Director), in the development &... ...-functional areas. Operates in compliance with regulations, company policies,...Local area
- ...Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible... ...Global Regulatory Lead (GRL), Associate Director, or Director), in the development &... ...‑functional areas. Operates in compliance with regulations, company policies,...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, REMS Regulatory Strategy & Compliance. Be the first to apply!
Related searches
- regulatory & compliance manager South San Francisco, CA
- healthcare compliance manager South San Francisco, CA
- director global regulatory affairs South San Francisco, CA
- head compliance South San Francisco, CA
- senior director regulatory affairs South San Francisco, CA
- compliance manager South San Francisco, CA
- regulatory affairs director South San Francisco, CA
- regulatory cmc manager South San Francisco, CA
- regulatory affairs manager pharmaceutical South San Francisco, CA
- compliance director South San Francisco, CA