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$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
- 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...Suggested
- 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
- ...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
- 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...
- 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
- 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...
- Marea Therapeutics, based in South San Francisco, seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for our US and global programs. The role reports to the Executive Director, Regulatory Affairs...
- 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
$232k - $274k
...Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors) Brisbane, California Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors) to join the Regulatory team. The successful candidate...For contractorsWorldwide- 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...
- ...Pharmaceuticals Inc. is seeking a senior Regulatory Affairs professional to lead... ...material reviews, ensuring regulatory compliance across our portfolio. You will serve as... ...key liaison with OPDP, shape labeling strategies, and guide cross-functional teams through...
- ...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...
$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- 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...
$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta... ...core prescribing information; oversee maintenance and compliance for marketed brands where applicable. Innovation and Ways...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week- ...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
- ...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...
$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 work- 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...
- Maze Therapeutics is seeking a Director of Medical Writing to lead the medical writing function across development programs, ensuring... ...consistency, and submission-readiness. Reporting to the VP of Regulatory and Quality Science, you will manage internal teams and external...
- ZBiotics, Inc. seeks a Director of Regulatory Affairs to own the US and international regulatory strategy for first-of-kind consumer biotechnology products. You will lead regulatory submissions, engage with FDA and global regulators, and shape policy while working cross...
$175k - $205k
Sr Manager/Assoc Director, CMC Regulatory Affairs San Diego, CA, South San Francisco, CA or remote... ...ensuring completeness, consistency, and compliance with regulatory requirements.... ...appropriate global regulatory filing strategies. Collaborate cross-functionally on the...Temporary workCasual workLocal areaRemote workWorldwideFlexible hours- ...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
$193.4k - $241.8k
...week. Position Summary Join a highly visible Regulatory Affairs team where you'll help shape promotional strategy for innovative therapies while serving as a trusted... ..., and other external communications to ensure compliance with applicable regulatory requirements while...Work at officeLocal areaRemote workNight shift3 days per week$220k - $270k
Senior Director/ Director, CMC Regulatory Affairs ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving... ...Responsibilities Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the...Currently hiring- Maze Therapeutics is seeking a Director of Medical Writing to lead the medical writing function across clinical programs, ensuring documents... ..., consistent, and submission-ready. Reporting to the VP of Regulatory and Quality Science, you will partner with Regulatory Affairs,...
- Denali Therapeutics, located in South San Francisco, is looking for an experienced professional to develop regulatory strategies for complex programs. The role requires 10+ years of experience in regulatory affairs, leadership in cross-functional teams, and expertise in...
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