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$160.5k
...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...Suggested- 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...Suggested
- 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...Suggested
$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...- ...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...
$170k - $230k
...Associate Director, Regulatory Strategy South San Francisco, California, United States, Princeton, New Jersey, United States Kardigan is... ...DSURs) to ensure alignment with regulatory strategy and compliance with applicable regulations and guidance Track submission...- ...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
...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$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 area$195.5k - $272.5k
Vir Biotechnology in San Francisco is looking for a highly motivated Director of Regulatory CMC to ensure regulatory compliance for clinical development and commercialization. The ideal candidate will bring extensive experience in pharmaceutical product development and...- 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...
$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...$193.4k - $241.8k
...Position Summary Responsible for leading the regulatory review of advertising, promotional, and... ...external communications to ensure compliance with applicable regulatory requirements... ..., and contributes to labeling strategies for regulatory submissions across Acadia...Full timeWork at officeLocal areaRemote workNight shift3 days per week$138.6k - $198k
...managed charging and virtual power plant programs by shaping the regulatory, policy, and market conditions that enable WeaveGrid’s growth.... ...Primary responsibilities include: Regulatory Strategy & Market Development Develop and execute WeaveGrid’s regulatory...Full timeRemote work$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- ...Director, Regulatory Affairs 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...For contractorsWork at office
$209.67k
...career in Advisory. KPMG is currently seeking a Director in M&A Services, Working Capital for our KPMG Strategy practice. Responsibilities : As a key... ...contains further information regarding KPMG's compliance with federal, state and local recruitment and hiring...Full timeWork experience placementH1bLocal area$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...$150.01k - $323.38k
...currently seeking a Manager to join our KPMG Strategy practice. Responsibilities : Lead... ...with the engagement Partner, Managing Director or Director to help build relationships... ...further information regarding KPMG's compliance with federal, state and local recruitment...Full timeH1bLocal area$150.01k - $323.38k
...KPMG is currently seeking a Manager in M&A Services for our KPMG Strategy practice. Responsibilities : Lead engagements and... ...attached link contains further information regarding KPMG's compliance with federal, state and local recruitment and hiring laws. No...Odd jobFull timeH1bLocal area$243k - $299k
...Compliance Counsel Neurodegenerative diseases are one of the largest... ..., reporting to the Senior Director, Healthcare Law and Compliance... ...business practices, and regulatory compliance as we prepare for... ...programs, and commercialization strategies. Qualifications J.D. degree...Work experience placementWork at officeLocal areaFlexible hours3 days per week- ...Regulatory Professional Sonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of adoptive... ...Proactively participate in design of global regulatory strategies for the development of gene therapy products for rare diseases...Remote work
$240k - $275k
...Position Summary The Director, Clinical Regulatory Affairs serves as a senior regulatory leader responsible... ...the global clinical regulatory strategy across Nektar’s development portfolio... ...scientific rigor, regulatory compliance, and internal alignment. Drive strategies...Local area$285k - $320k
...clarity, speed, and quality of work. What You’ll Do Lead CMC regulatory strategy and execution across development and post‑approval programs... ...strategies to support program objectives and regulatory compliance Coordinate and review responses to CMC‑related health authority...Full timeWork at officeRemote workFlexible hours$280k - $320k
International Executive Service Corps is seeking a Sr. Director of Medical Writing to oversee all scientific, medical, and regulatory writing activities. This role ensures full life-cycle support from clinical protocols through regulatory submissions. The ideal candidate...- 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
- ...San Francisco is seeking an Associate Director, Trial Master File (TMF), to provide oversight... ..., ensuring inspection readiness and compliance. The ideal candidate will possess... ...strong leadership skills, and expertise in regulatory standards. Structure offers competitive...
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