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
- Zai Lab Limited seeks an Associate Director of Regulatory Affairs for onsite work in South San Francisco. This role leads regulatory strategy and execution for clinical programs, coordinating IND submissions and health authority interactions with cross-functional teams...SeniorRegulatory
- ...Lab is seeking an Associate Director, Regulatory Affairs in South San Francisco, CA to lead regulatory strategy and execution for clinical programs across... ...regions. This role collaborates with senior leadership to prepare submissions and manage health authority...SeniorRegulatory
- Kardigan is seeking a Senior Director, CMC Regulatory to lead regulatory strategies and interactions for late-stage programs focused on cardiovascular therapies. This role reports to the Head of CMC Regulatory and collaborates with cross-functional teams to align programs...SeniorRegulatory
- 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...SeniorRegulatory
- 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,...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
- ...South San Francisco, CA, is seeking a Director of Regulatory Affairs CMC to lead global regulatory strategies for small molecule programs from IND/CTA through... ...Clinical and Operations to ensure timely, compliant submissions and lifecycle activities, with risk mitigation...Regulatory
- ...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
- ...Therapeutics, based in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory planning and tactical... ...with internal teams and external partners to drive submissions and regulatory strategy. The ideal candidate has >8 years in drug development...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
$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
- ...Technical Officer, we are hiring a Director, CMC Regulatory Affairs to join our Technical... ...Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements... ...manage all CMC aspects of regulatory submissions, including strategy for updating...SeniorRegulatory
$248k - $310k
...real difference, every day. Position Title: Senior Director, CMC Regulatory Department: Regulatory Affairs Reports To: Head... ...who will help define CMC Regulatory strategies and successfully execute them in submissions and health authority interactions, in close collaboration...SeniorRegulatory- 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...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- ...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
- ...energy and data center assets are deployed. We are seeking a Senior 3PL Strategy & Relationship Manager to shape and own Crusoe’s logistics... ...and manage a regionalized 3PL network, align tax and regulatory compliance with project funding, optimize fungible inventory...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
- ...Therapeutics is seeking a Sr. Director, Head of Regulatory & Medical Writing to lead the medical writing group and shape the strategy for key regulatory documents. You will... ...experience directing regulatory writing for major submissions (NDA, BLA, MAA), a deep understanding of...SeniorRegulatoryContract work
- ...Pharmacology Documentation group. The role focuses on generating preclinical reports and submission modules to support development programs, with collaboration across research and regulatory functions. The successful candidate will manage multiple programs, prioritize...SeniorRegulatory
- ...experienced Medical Writer to join the Nonclinical Pharmacology Documentation group. You will generate preclinical reports and regulatory submission modules, partnering with research and regulatory teams to ensure high-quality scientific and regulatory documents across...SeniorRegulatory
$258k - $320k
...Primary Function: Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological projects... ...development, including strategy, dossier preparation and submissions, and responses to the regulatory agencies’ requests. This...SeniorRegulatoryWork at officeWorldwideRelocation package- ...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
$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
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