Senior Clinical Program Manager - Regulatory Submissions
Mindlance
A national recruiting company is seeking a skilled Project Manager to oversee project management of drug development processes. Responsibilities include leading cross-functional teams, managing regulatory submissions, and ensuring projects meet business needs. Ideal candidates will possess strong leadership, project management skills, and extensive experience in the pharmaceutical industry. This position requires a Bachelor's degree and relevant experience, with opportunities for career advancement within the organization. #J-18808-Ljbffr Mindlance
$190k - $210k
A clinical stage biotechnology company seeks a motivated Project Manager in South San Francisco. The role involves partnering with program leads to drive clinical programs, managing timelines, budgets, and regulatory submissions. Candidates should have over 7 years of...Senior- ...based in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory planning... ...for US and international development programs. This on-site role requires coordinating... ...teams and external partners to drive submissions and regulatory strategy. The ideal...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
- Denali Therapeutics Inc. seeks a senior regulatory affairs leader to develop and execute regulatory... ...strategy for complex development programs in neurodegenerative diseases. You... ...interactions with global Health Authorities, manage submissions, and guide lifecycle management...SeniorRemote job
$263.88k - $307.86k
## Senior Director, Regulatory Affairs REMS ProgramApplylocations: South San Francisco... ...Regulatory Affairs, REMS Program is responsible for leading... ..., including original REMS submissions, assessments,... ...Committees, inspections)* Manage all aspects of preparation...SeniorFor contractors$165k - $180k
...Senior Technical Program Manager, Compliance Amperesand is reinventing how the world powers its most... ...at the intersection of engineering, regulatory requirements, quality, and... ...ensuring that testing, certification submissions, and regulatory approvals are sequenced...SeniorTemporary workLocal areaShift work$164k - $205k
Revolution Medicines is a late-stage clinical oncology company developing... ...for the successful management of all aspects of clinical trials... ...timelines and designated program budgets. Partner with cross... ...clinical study and regulatory documentation and SOPs. Experience...SeniorFull timeContract workTemporary workWork at office$149.8k - $240.1k
...to the world. Progress starts with you.Job DescriptionThe Senior Program Manager, Sanctions Compliance will provide support for sanctions screening... ...controls testing, monitoring, risk mitigation, and regulatory reporting. Preferred Qualifications:7 or more years of relevant...SeniorFull timeWork experience placementWork at officeLocal area- ...XandYouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg... ...including Public Affairs, Clinical Development, Legal, and... ...and review of regulatory submissions consistent within US and Canada... ...and the Quality Dossier Program (QDP). Qualifications Minimum...Senior
$180k - $195k
...Therapeutics is a clinical-stage biotechnology... ...The company’s lead program, MAR001, is being developed... ..., from interns to senior leaders. Our... ...Reporting to the Director, Regulatory Affairs, the Senior Manager, Regulatory Affairs... ..., and timely submission of regulatory...SeniorFull timeFor contractorsLocal area3 days per week- 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...Senior
- ...YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg... ...including Public Affairs, Clinical Development, Legal, and others... ...and review of regulatory submissions consistent within US and Canada... ...and the Quality Dossier Program (QDP). Qualifications...SeniorLocal area
$115.6k - $214.6k
...utilizing unique perspectives and backgrounds, in order to improve the outcomes for our patients.The Research and Early Development Program Management Group is responsible for driving drug development molecule, strategy, and partnering teams to advance science and medicine...SeniorFull timeLocal areaRelocation package- Calico Life Sciences is looking for a Regulatory Director in South San Francisco to develop and implement innovative... ...collaboration with various teams, overseeing regulatory submissions, and guiding development programs. The ideal candidate will have a Master’s degree in...
- ...seeking a Director of Regulatory Affairs CMC to lead... ...strategies for small molecule programs from IND/CTA through... .../MAA and lifecycle management. Reporting to the VP... ...with CMC, Quality, Clinical and Operations to... ...ensure timely, compliant submissions and lifecycle...
- Maze Therapeutics is seeking a Project Manager, Regulatory Affairs to drive regulatory planning,... ...functional coordination across development programs. You will partner with Regulatory... ...ensure timely execution of milestones and submission workstreams. Reporting to the VP,...
- ...Inc. invites an experienced Director/Senior Director of Regulatory Affairs (Strategy, Oncology - Solid... ...regulatory strategy, guide high-quality submissions, and work with cross-functional... ...regulatory approvals and life cycle management. This onsite Brisbane, CA role reports...Senior
- 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 requires...SeniorFull time
- ...Therapeutics, Inc. is seeking a Director/ Senior Director of Regulatory Affairs (Strategy, Oncology -... ...strategy and lead high-quality submissions. You will partner with SVP... ...drive registrations and lifecycle management across programs, including interactions with health...Senior
- Marea Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC... ...Regulatory Affairs and will own CMC submissions and alignment with Tech Ops. On-site... ...The candidate will lead CMC strategy, manage regulatory interactions, and build a...SeniorWork at office2 days per week
$265k - $285k
...Senior Director, Regulatory Affairs San Francisco Bay Area At Annexon... ...advancing a late-stage clinical platform of novel... ...registration, and life-cycle management of innovative programs within the Annexon... ...regulatory documents and submissions related to applicable programs...SeniorWork at officeRemote workFlexible hours$374k
...Description:The Medical Director/Senior Medical Director at Calico will report to the Head of Clinical Sciences and will be... ...areas to shape new clinical programs at multiple points in their... ...Brochures, Clinical Study reports, regulatory submissions and responses, and other...Senior$15 per hour
...responsible for assisting potential borrowers and current customers with questions regarding loan products, evaluating vehicles, managing loans and payments, and maintaining regular communication with customers regarding their accounts. This includes making courtesy calls...SeniorHourly payFull timeTemporary workMonday to Friday- Marea Therapeutics in South San Francisco is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory... ...with hands‑on execution to drive CMC development and submissions, including device-related #J-18808-Ljbffr Marea TherapeuticsSeniorFull time
$166k - $195k
...Protect Humankind!Vaxcyte is a clinical-stage vaccine innovation... ....Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor... ...of regulatory CMC submissions — including BLAs and Prior... ...potential risks.Contribute to program cross-functional working plans...Senior3 days per week$324k - $409k
...We are advancing a clinical‐stage pipeline of... ...Position Summary:The Senior Medical Director... ...across portfolio programs, assisting in developing... ...in key regulatory interactions and document... ...activities: Manage interactions with... ...in preparation and submission of clinical trial...SeniorContract work- ...Pharmaceuticals is a clinical stage biopharmaceutical... ...a Director, CMC Regulatory Affairs to join our Technical... ...clinical development programs for oncology products... ...trials, including management and preparation of... ...aspects of regulatory submissions, including strategy for...Senior
$248k - $310k
...day. Position Title: Senior Director, CMC Regulatory Department:... ...Kardigan’s late-stage clinical assets through clinical... ...successfully execute them in submissions and health authority... ...are aligned with program objectives and timelines Proactively manage regulatory CMC...Senior- ...Therapeutics is a clinical-stage biotechnology... ...company’s lead program, MAR001, is being... ..., from interns to senior leaders. Our environment... ...Senior Director, Regulatory Chemistry,... ...regulatory strategies and submissions related to the... ...strategically and manage hands on execution...SeniorFull timeWork at office2 days per week
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