Senior Manager, Regulatory Affairs — Global Submissions & Strategy
BioSpace
Marea Therapeutics, based in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory planning and tactical execution for US and international development programs. This on-site role requires coordinating with internal teams and external partners to drive submissions and regulatory strategy. The ideal candidate has >8 years in drug development with strong regulatory affairs experience, including eCTD submissions, and familiarity with cardiometabolic targets. #J-18808-Ljbffr BioSpace
- ...Facebook,Instagram,XandYouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the... ...responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory...Senior
- .... 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... ...and lifecycle management across programs, including...Senior
- ...Instagram , X and YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the... ...responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory...SeniorFull timeLocal area
- 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...Suggested
- 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
- ...an experienced Director/Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors)... ...develop and execute the global regulatory strategy, guide high-quality submissions, and work with cross-functional... ...approvals and life cycle management. This onsite Brisbane, CA...Senior
- ...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... ...Executive Director of Regulatory Affairs and requires strong strategic...SeniorFull time
- ...San Francisco, seeks a Senior Director, Regulatory Chemistry,... ...CMC) to lead regulatory strategies and submissions for our US and global programs. The role reports... ...Director, Regulatory Affairs and collaborates across... ...filings for biologics, manage the CMC document control...Senior
- ...Therapeutics is seeking a Senior Director, Regulatory Chemistry,... ...shape regulatory strategies for manufacturing across the US and global markets. The role... ...Director of Regulatory Affairs and will own CMC submissions and alignment with... ...CMC strategy, manage regulatory interactions...SeniorWork at office2 days per week
- VetJobs in Princeton, New Jersey, is seeking a regulatory affairs leader to develop and manage Global and US regulatory activities for Development... ...in plans. You will formulate US regulatory strategy, lead global submissions, and provide input on target product profiles...
- ORIC Pharmaceuticals, Inc. is seeking a Senior Director/Director, CMC Regulatory Affairs to lead global CMC regulatory strategies and documentation for oncology... ...preparation of Module 2/3, IMPD, and post-submission activities, manage timelines, and mentor a regulatory...
- 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...Senior
- ...seeking aSenior Vice President, Head of Regulatory Affairs for a clinical-stage biotechnology... ...regulatory function and reports to the senior leadership team. The candidate will develop and execute global regulatory strategies to advance the pipeline from preclinical...
- 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...
$240k - $275k
...International Executive Service Corps is hiring a Director of Clinical Regulatory Affairs to shape and execute the global clinical regulatory strategy. The role involves overseeing clinical submissions and ensuring compliance with regulatory requirements. The ideal...Senior$180k - $195k
...member, from interns to senior leaders. Our... ...Reporting to the Director, Regulatory Affairs, the Senior Manager, Regulatory Affairs... ...development strategies. This is a full-time... ...preparation, and timely submission of regulatory... ...and filings Review global regulatory submissions...SeniorFull timeFor contractorsLocal area3 days per week- A growing biotechnology company in San Francisco is seeking a Senior Director, Regulatory Affairs to lead their global regulatory strategy and oversee submission activities. The position requires over 10 years of regulatory affairs experience, including 5 years at the director...
- ...located in Brisbane, California, seeks a Senior Director of Regulatory Affairs to lead global regulatory strategies for the Annexon portfolio. You will guide regulatory plans, manage agency interactions, and oversee all submissions to authorities such as FDA and EMA,...
$232k - $274k
...Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid... ...and executing the global regulatory strategy... ...nonclinical and clinical submissions and interactions in... ...and life cycle management activities. This position... ...: $232K - $274K Senior Director:$279K - $33...SeniorFor contractorsWorldwide$244k - $305k
...Opportunity: The Senior Director, Molecule Global Regulatory Lead will develop... ...global regulatory strategy for assigned molecule... ...and lifecycle management. This leader will... ...teams. Regulatory Submission Leadership Provide... ...years of regulatory affairs experience within...SeniorFull timeLocal area- Zipline, a leading autonomous logistics company, seeks an experienced IP Counsel to lead the global patent portfolio and strategy. You will partner with hardware, autonomy, software, and product teams to draft, prosecute, and defend patents while guiding external counsel...Senior
- Visa Consulting & Analytics (VCA) seeks a Senior Director, Global Strategy to shape and govern VCA's global strategy, operating model, and performance agenda. The role partners with executive leadership to translate priorities into roadmaps, OKRs, and accountable governance...Senior
- 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...Senior
- EY-Parthenon, part of EY, seeks a Senior Director to lead Supply Chain strategy and execution across complex transactions. You will work with global teams on M&A integrations, divestitures,... ...knowledge to drive performance improvements, manage cross‑functional teams, and deliver...Senior
$138k - $210k
...payments and financial platform for global businesses. Powered by our... ...integrated solutions to manage everything from business accounts... ...driven insights and creative strategies, we ensure Airwallex stands... ...across all regions. The Senior Manager, Global Performance Marketing...SeniorTemporary workLocal areaWorldwide- ...hiring a Director, CMC Regulatory Affairs to join our Technical Operations... ...all CMC regulatory strategies in compliance with global regulatory requirements... ...trials, including management and preparation of CMC... ...aspects of regulatory submissions, including strategy for...Senior
- ...seeks a Director of Clinical Regulatory to oversee multiple clinical... ...The role involves overseeing global Health Authority interactions... ...teams, and developing regulatory strategies. An ideal candidate will have... ...of experience in regulatory affairs, strong strategic skills, and...
$175k - $205k
...to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC... ...support through QC review of submission components, including CMC documents... ...development of appropriate global regulatory filing strategies. Collaborate cross-functionally...SeniorTemporary workCasual workLocal areaWorldwideFlexible hours- ...Francisco is seeking a Senior Director, Regulatory Chemistry,... ...to lead regulatory strategies for manufacturing products... ...products in the US and globally. The role reports to... ..., Regulatory Affairs and collaborates with... ...CMC development and submissions, including device-related...SeniorFull time
$150k
Premier Research Group is seeking a Regulatory Strategy Director for the Bay Area or Boston. You will lead regulatory program strategies,... ...projects. This role requires deep expertise in regulatory submissions, with preferred qualifications being a relevant degree and...Senior
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