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
$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$270k - $300k
Senior Director, Regulatory Affairs - Oncology Strategy Pliant Therapeutics is a clinical‑stage biopharmaceutical company and leader in the discovery and... ...Affairs will report to the Vice President, Regulatory & Compliance and is responsible for leading, developing and...SuggestedRemote jobFull timeTemporary work- Senior Director, Regulatory Affairs (Strategy, Hematology Oncology) Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery... ...with cross‑functional teams to ensure product compliance throughout the development lifecycle. Monitor and assess...SuggestedFor contractors
$170k - $230k
...Associate Director, Regulatory Strategy Princeton, New Jersey, United States, South San Francisco, California, United States Kardigan is... ...DSURs) to ensure alignment with regulatory strategy and compliance with applicable regulations and guidance Track submission...Suggested- ...and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing... ...the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages...SuggestedTemporary workLocal areaWorldwide
$225k - $262.5k
Cytokinetics, located in San Francisco, is seeking a Director of Regulatory Affairs to lead regulatory support for its biopharmaceutical... ...affairs. This role involves formulating regulatory strategies, ensuring compliance with international guidelines, and mentoring junior...$270k - $300k
Pliant Therapeutics, Inc. is looking for a Senior Director, Regulatory Affairs for Oncology Strategy in South San Francisco, CA. This remote role leads the development and execution of regulatory strategies across the product lifecycle. Candidates should have at least...Remote job- AstraZeneca in South San Francisco is looking for a Senior Director in Oncology Cell and Gene Therapy Regulatory Affairs. The role involves leading the global regulatory strategy for complex CGT products, ensuring efficient approval processes, and coaching other team members...
- Allergan is seeking a Director of Regulatory Affairs to lead global regulatory strategies in South San Francisco. This role involves managing the Global Regulatory Product Team, ensuring compliance with regulatory requirements, and actively participating in strategic negotiations...
- ...South San Francisco is looking for a Senior Director, Medical Writing to lead the strategy and development of clinical and regulatory documents across oncology programs. This... ...medical writing team and managing projects in compliance with global regulatory standards. The...
$232.8k - $271.6k
...company in South San Francisco is seeking a Director, Treatment Experience Strategy & Operations. This role is essential for enhancing patient access and compliance with regulatory requirements. Responsibilities include managing REMS compliance, optimizing vendor...- ...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...
- Eight Sleep is looking for a Director of Medical Products to build a medical business focused on sleep and health. The role includes leading regulatory and reimbursement strategies, collaborating with R&D and engineering teams, and driving product development to enhance...
$220k - $270k
...the Chief Technical Officer, we are currently hiring a Director, CMC Regulatory Affairs, to join our Technical Operations team. This position... ...Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development...Currently hiring$302.01k - $390.83k
...leadership to the global inflammation regulatory organization to advance Gilead's portfolio... ...all activities are conducted in full compliance with applicable laws, regulations, ICH... ...ability to assess their impact on business strategy. Demonstrated capability to lead...For contractorsLocal areaWorldwide$211k - $258.67k
Denali Therapeutics Inc in South San Francisco seeks a Regulatory Affairs professional to develop and implement regulatory strategies for complex programs. The ideal candidate has over 10 years of experience, including 8 years in regulatory affairs, and excels in communication...$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...$144k
...Principal Business Unit: Strategy & Growth Work Type: Hybrid... ...leading a team focused on regulatory and policy advocacy and new... ...Manager will report to the Director of Clean Energy Transportation... ...program adherence to regulatory compliance policies and support...Work experience placementWork at officeLocal areaRemote workFlexible hours- ...Purpose: AbbVie seeks a Director for the Aesthetics & Regenerative Medicine HEOR-Strategy team to lead strategic research... ...research, HEOR strategy, and regulatory submissions, with responsibilities... ...must be able to direct compliance knowledgeably and expeditiously...Temporary workWork experience placementLocal area
- ...Context The MENA Catalysts is a government relations strategy firm for fintech and crypto multinationals. The firm is looking for a senior director of fintech legislative and regulatory affairs for global clients, expanding in the Middle Eastern economies. The selected...Full timeFor contractorsWork at office
- ...dynamic biopharmaceutical company in San Francisco seeks a Regulatory Affairs Director to lead strategies for late-stage oncology assets. Responsibilities... ...submissions, engaging with FDA and EMA, and ensuring compliance with regulations. Candidates need a bachelor's degree...Work at office
- ...An innovative firm seeks a Senior Director of Fintech Legislative and Regulatory Affairs to shape the future of fintech in the Middle East. This role involves crafting regulatory strategies, managing complex projects, and leading market expansion for global clients. The...
$175k - $220k
...complex science that the world hasn't seen before. As the Director, Dx Strategy & Commercialization, you will own the end-to-end lifecycle... ...landscapes, white space opportunities, and stay abreast of evolving regulatory requirements (e.g., FDA oversight of LDTs). Financial...Shift work$210k - $275k
...information at Job Purpose/Summary: We seek an experienced Regulatory professional to manage regulatory activities associated with... ...: Proactively participate in design of global regulatory strategies for the development of cell therapy products Oversee and manage...Remote work$235k - $285k
...is seeking an experienced and highly motivated Director/Senior Director of Regulatory Affairs to lead regulatory strategy and execution across our discovery and... ...CMC, Nonclinical, and Clinical teams to ensure compliance with applicable regulations and consistent messaging...Full time$300k - $360k
Ripple is seeking a Senior Director of Governance, Risk and Compliance in San Francisco. This leadership role involves defining the GRC strategy, leading a diverse team, and ensuring compliance with various regulations. Candidates should have over 15 years of experience...$275k - $280k
...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... ..., ensuring technical consistency and compliance across all stages of the product...$300k - $400k
...Regulatory Affairs Director / VP - Specialty Pharma | Bay Area (Hybrid) A specialty pharmaceutical company based in the San Francisco Bay Area... ...senior regulatory leader to own and drive global regulatory strategy across their development programs. This is a high-impact...Work at officeLocal areaRelocation$225k - $262.5k
...Director, Regulatory Affairs Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering... ...implementation of US and international development strategies. Responsibilities: Formulates regulatory strategies...For contractors- ...Head of Regulatory Strategy About the Company A specialty pharmaceutical company based in the San Francisco Bay Area Industry Pharmaceuticals Type Privately Held About the Role The Company is seeking a Head of Regulatory Strategy to take on a senior...
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