Senior RA CMC Leader: Regulatory Strategy & Submissions
Allergan
The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) leads initiatives to develop and manage regulatory strategies for CMC submissions, including INDs/CTAs and amendments. This role builds relationships across Regulatory Affairs, Operations and R&D to drive first-pass approvals and prepares content for agency submissions. The candidate will serve as strategic liaison with regulatory authorities, negotiate and influence teams to maximize chances of successful #J-18808-Ljbffr Allergan
- Veratherapeuticsinc seeks a Senior Manager, Regulatory CMC to manage regulatory submissions and activities within a dynamic team. This role requires strong regulatory knowledge, organizational skills, and the ability to lead cross-functional projects. Candidates should...SeniorRegulatory
- 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...SeniorRegulatory
- 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...SeniorRegulatoryFull 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... ...Regulatory Affairs and will own CMC submissions and alignment with Tech Ops. On-site...SeniorRegulatoryWork at office2 days per week
- ...San Francisco is seeking an Associate Director of CMC Program Management to lead end-to-end CMC strategies, cross-functional execution, and external partnerships... ..., and ability to navigate complex programs across regulatory and commercial #J-18808-Ljbffr ORIC...SeniorRegulatory
- .... in South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across oncology programs. You will collaborate... ...develop regulatory strategies and prepare global submissions. The role requires strong scientific writing,...Regulatory
- 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...Regulatory
$182.1k - $338.3k
...all.The Principal Content & Evidence Submission Strategy Lead is focused on developing the medical... ...silos, interpret external legal and regulatory landscapes, and lead cross-functional... ...influence, coach, and advise teams and leaders to develop valuable solutions and organize...RegulatoryFull timeLocal area- ...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... ...to drive CMC development and submissions, including device-related #J-18808-Ljbffr...SeniorRegulatoryFull time
- ...assisting a late-stage biopharmaceutical company in seeking a Senior Director, Regulatory Affairs, CMC. This lead CMC regulatory expert role partners with... ...Operations, and Development teams to drive global CMC strategy and execution through late-stage development and...Regulatory
$220k - $270k
...currently hiring a Director, CMC Regulatory Affairs, to join our... ...and direct all CMC regulatory strategies in compliance with global regulatory... ...CMC aspects of regulatory submissions, including strategy for... ...level and $250,000-$300,000 for Senior Director, level candidates ....SeniorRegulatoryH1bCurrently hiring$140k - $214k
...Position Summary:Vera is seeking a Senior Manager, Regulatory CMC to join an experienced, fast-paced and... ...teamto lead and support regulatory submissions and activities in the US and globally... ...that support product development strategy.Author and review CMC modules of applications...SeniorRegulatoryContract workFor contractorsFlexible hours$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South San Francisco, Californiatime... ...for the product development strategy for assigned program(s) across the clinical... ...clinical supply chain, CMC, quality, regulatory, program & portfolio management.This role...SeniorRegulatory- ...The Associate Director Regulatory Affairs, Chemistry,... ...Manufacturing and Controls (CMC) works with internal... ...CMC regulatory strategies that enable first pass... ...strategy for regulatory submissions, including INDs/CTAs and... ...initiatives internal to RA CMC. Represents CMC...Regulatory
$245k - $285k
...leading and managing the regulatory affairs within CMC function. This includes developing... ...leading regulatory CMC strategies and activities for a... ...position assists corporate senior management in understanding... ...all types of regulatory CMC submissions including type B, C, D...SeniorRegulatoryContract work- ORIC Pharmaceuticals, Inc. is seeking a Senior Director/Director, CMC Regulatory Affairs to lead global CMC regulatory strategies and documentation for oncology programs. Based... ...preparation of Module 2/3, IMPD, and post-submission activities, manage timelines, and mentor a...Regulatory
- ...every member, from interns to senior leaders. Our environment is dynamic, with... ...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...SeniorRegulatoryFull timeWork at office2 days per week
- Maze Therapeutics seeks a Senior Manager, Trial Master File (TMF) to lead TMF strategy and governance across the clinical portfolio. You will drive the in-house... ...years in TMF or clinical operations, with strong regulatory knowledge and leadership capabilities in a...SeniorRegulatory
- ...an Associate Director in Toxicology to lead nonclinical safety strategies for multiple programs. You will play a key role in... ...influencing program decisions that ensure patient safety and regulatory success. The ideal candidate holds a PhD with 10+ years of experience...SeniorRegulatory
- ...Francisco, CA, seeks a Senior Director of Safety Biostatistics... ...drives statistical strategy across drug safety and... ...Development, Regulatory Affairs, and Data Management. The leader will guide protocol development... ..., DSURs and regulatory submissions, oversee internal/...SeniorRegulatory
- Allergan is seeking a Senior Manager, Clinical Product Supply, to ensure the delivery of high-quality clinical supplies compliant with global regulatory requirements. You will lead cross-functional teams and provide quality oversight across the supply chain. The ideal...SeniorRegulatory
- ...Therapeutics, Inc. invites an experienced Director/Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team... ...the global regulatory strategy, guide high-quality submissions, and work with cross-functional partners to enable timely...SeniorRegulatory
- 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...SeniorRegulatory
$280k - $310k
...seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic... ...for all CMC-related submissions: strategic planning, execution... ...implementation of all regulatory CMC strategies to support market...SeniorRegulatoryLocal area$171k - $223k
...over 10 years of industry experience to lead nonclinical safety strategies across discovery and development stages. This role involves mentoring junior scientists, providing input on regulatory submissions, and developing innovative toxicology processes. We offer a competitive...SeniorRegulatory$166k - $195k
...making.Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the... ...coordination, and execution of regulatory CMC submissions — including BLAs and Prior Approval... ...to manage changes in processes, strategy, and competitive landscape.Strong team...SeniorRegulatory3 days per week- Denali Therapeutics Inc is seeking an experienced Regulatory Project Manager to drive the regulatory strategy and timelines across a portfolio of... ...Writing, Operations, and development SMEs to ensure submissions stay on track and aligned with program goals. The...SeniorRegulatory
- Senti Biosciences seeks a senior regulatory leader to own and drive CMC regulatory strategies for a complex cell therapy portfolio. You will coordinate global submissions, interact with agencies, and guide cross-functional teams in a fast-paced environment in South San...Regulatory
- 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... ...various teams, overseeing regulatory submissions, and guiding development programs. The...Regulatory
$175k - $205k
...Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of... ...regulatory support through QC review of submission components, including CMC documents... ...global regulatory filing strategies. Collaborate cross-functionally...SeniorRegulatoryTemporary workCasual workLocal areaWorldwideFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior RA CMC Leader: Regulatory Strategy & Submissions. Be the first to apply!
- member team lead South San Francisco, CA
- team leader production South San Francisco, CA
- site leader South San Francisco, CA
- team leader training South San Francisco, CA
- team lead data science South San Francisco, CA
- market leader South San Francisco, CA
- compliance team leader South San Francisco, CA
- manufacturing team lead South San Francisco, CA
- focus group leader South San Francisco, CA
- team lead South San Francisco, CA

