Senior Director, CMC Regulatory Strategy
Kardigan, Inc.
Kardigan, Inc. seeks a Senior Director, CMC Regulatory to lead regulatory activities for late-stage cardiovascular assets. You will define and execute CMC strategies, interact with global health authorities, and ensure timely, compliant submissions across programs. The ideal candidate has 10+ years in CMC regulatory affairs, strong FDA/EMA knowledge, and a track record of global submissions and cross-functional leadership. #J-18808-Ljbffr Kardigan, Inc.
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Director, CMC Regulatory Strategy in South San Francisco, CA vacancy
- 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,...Senior
- 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...SeniorFull time
- 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...SeniorWork at office2 days per week
- ...Reporting to the Chief Technical Officer, we are hiring a Director, CMC Regulatory Affairs to join our Technical Operations team. This role leads... ...Responsibilities Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the...Senior
- Marea Therapeutics seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for the manufacturing of our products in the US and globally. The incumbent will oversee Regulatory CMC aspects of product...Senior
- Marea Therapeutics in South San Francisco is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies for manufacturing products in the US and globally. The role reports to the Executive Director, Regulatory Affairs...SeniorFull time
$248k - $310k
...to make a real difference, every day. Position Title: Senior Director, CMC Regulatory Department: Regulatory Affairs Reports To : Head of CMC... ...motivated individual who will help define CMC Regulatory strategies and successfully execute them in submissions and health...Senior$245k - $285k
...responsible for leading and managing the regulatory affairs within CMC function. This includes developing and leading regulatory CMC strategies and activities for a complex cell... ...addition, the position assists corporate senior management in understanding CMC Regulatory...SeniorContract workSenti Biosciences
South San Francisco, CA20 days ago$275k - $280k
...allowing people to live longer, healthier, and happier lives! About the Job: The Senior Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies to accelerate clinical development and ensure seamless commercialization. This...SeniorLocal areaRelocationRelocation package3 days per week$258k - $320k
...team of approximately 2000 employees. Job Description Primary Function: Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological projects across all phases of development, including strategy, dossier...SeniorWork at officeWorldwideRelocation packageZai Lab (US) LLC
South San Francisco, CA12 days ago$260k - $295k
...of every member, from interns to senior leaders. Our environment is dynamic... ...are seeking a motivated Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to be responsible for the development of regulatory strategies and submissions related to the manufacturing...SeniorFull timeWork at officeLocal area2 days per week$280k - $310k
...get it done, and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will... ...development and implementation of all regulatory CMC strategies to support market applications, post-marketing CMC commitments...SeniorLocal 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...
$175k - $205k
...Position Summary: Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC Regulatory Affairs... ...development of appropriate global regulatory filing strategies. Collaborate cross-functionally on the eTMF processes...SeniorTemporary workCasual workLocal areaWorldwideFlexible hoursErasca
South San Francisco, CA7 days ago- 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...Senior
- 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...Senior
- Nurix Therapeutics, Inc. is seeking a Director/Senior Director, Regulatory Affairs to shape global regulatory strategy in oncology and execute high-quality submissions for early and late-stage programs. You will collaborate with cross-functional teams and health authorities...Senior
- Corvus Pharmaceutical, a clinical-stage biopharmaceutical company, is seeking a Director of Regulatory Affairs CMC reporting to the VP of Regulatory Affairs to lead global CMC regulatory strategies for clinical-stage small molecule programs. This role partners with CMC,...
- 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...
- Kardigan in Princeton, NJ is seeking a Senior Director, Clinical Pharmacology to lead strategies across cardiovascular development and regulatory interactions with FDA and global health authorities. You will drive dose selection, exposure‑response analyses, PK/PD modeling...Senior
- ...are seeking an experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory consulting... ..., expedited pathways, regulatory risk assessment, CMC, nonclinical and clinical requirements, labeling,...Senior
$261k - $304.5k
Cytokinetics is seeking a Senior Director, CMC Lead to drive CMC product development for their pipeline. This role will be responsible for product development strategy across clinical life-cycles, leading cross-functional teams with a focus on drug substance, drug product...Senior- Marea Therapeutics, based in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory planning and tactical execution... ...and external partners to drive submissions and regulatory strategy. The ideal candidate has >8 years in drug development with...Senior
$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... ...with cross-functional stakeholders and senior leadership and externally with CMOs and...- 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...
$166k - $195k
...communications and decision making.Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the company’s project... ...independently and ability to manage changes in processes, strategy, and competitive landscape.Strong team management skills, including...Senior3 days per week- Revolution Medicines is seeking a Senior Director, Molecule Global Regulatory Lead to shape and execute regulatory strategy from early development through registration and lifecycle management. The role leads global interactions with authorities and coordinates cross-functional...Senior
- Senior Director Regulatory Affairs Strategy My client is seeking a highly experienced and strategic Director or Senior Director of Regulatory Affairs to lead global regulatory strategies supporting product development and commercialization across key international markets...Senior
- ...Facebook, Instagram, X and YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the... ...the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the...SeniorLocal area
$232k - $274k
Job Summary: Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team... ...of view Salary Range: Director: $232K - $274K Senior Director:$279K - $331K Location: Brisbane, CA (Onsite...SeniorFor contractorsWorldwide
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, CMC Regulatory Strategy. Be the first to apply!
Related searches
- manager regulatory affairs South San Francisco, CA
- sr. manager regulatory compliance South San Francisco, CA
- senior regulatory manager South San Francisco, CA
- compliance director South San Francisco, CA
- regulatory manager South San Francisco, CA
- senior director regulatory affairs South San Francisco, CA
- compliance manager South San Francisco, CA
- training and compliance manager South San Francisco, CA
- director global regulatory affairs South San Francisco, CA
- regulatory affairs director South San Francisco, CA