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
- ...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
$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, ComplianceAmperesand is reinventing how the world powers its most critical... ...the intersection of engineering, regulatory requirements, quality, and... ...ensuring that testing, certification submissions, and regulatory approvals are sequenced...SeniorTemporary workLocal areaShift work$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$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- ...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
$181.26k - $211.47k
## Senior Manager, Regulatory Operations & SystemsApply: South San Francisco, California: Full time:... ...Regulatory Operations, Quality, and Clinical teams to align RIM capabilities with... ...operations systems, and global regulatory submission requirements.* Strong organizational,...SeniorFull time$150k - $180k
...strategic business outcomes, including cost management, rapid innovation, and environmental... ...About the Role We're hiring a Senior Technical Program Manager to drive delivery across... ...Nscale does not accept unsolicited candidate submissions from recruitment agencies....SeniorFull timeFlexible hours$175k - $195k
...seriously.POSITION SUMMARYThe Senior Manager (SM), Regulatory Affairs Labeling will play... ..., Medical Affairs, Legal, Clinical Development, Commercial... ...content for assigned programs of marketed product(s) and... ...colleagues on regulatory submissions of labeling documents (package...SeniorLocal areaFlexible hours- 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...
- ...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
$218.06k - $327.09k
...to set the global regulatory vision for... ...leads high-impact programs across cancer, immune... ...stage through BLA submission, ensuring an efficient... ...objectives with clinical, CMC, safety and... ...mitigations to senior leadership to... ...Delivery and Milestone Management: Oversee all...SeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week- 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
- AbbVie seeks a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance and deployment of data standards across clinical trials, ensuring conformance to CDISC and industry best practices including SDTM and ADaM. You will lead cross-functional teams to...
$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$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$170k - $240k
Litigation Marketing Senior Manager - RegulatoryCooley is seeking a Litigation... ...Marketing Senior Manager - Regulatory to join the Marketing and... ...the narrative strategy and submission process for legal... ...level strategic planning.GTM Program Definition: Define the content...SeniorFull timeTemporary workWork at officeImmediate startFlexible hoursWeekend work- ...difference, every day. Position Title: Senior Manager, Statistical Programming Department: Clinical Data Sciences & Analytics... ..., ADaM, and TLF for CSR and regulatory requests, publication needs, and... ...standards (SDTM, ADaM) and regulatory submission requirements. Good knowledge of...SeniorFor contractors
$270k - $295k
...targeted small molecule programs with potential for... ...for success in the clinic. The successful... ...and highly motivated Senior Director of Regulatory Affairs to lead regulatory... ...plans and submissions to support preclinical... ...authority inquiries. Manage interactions with FDA...SeniorFull time- ...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
$218.06k - $327.09k
...Job Description The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the... ...Franchise GRL on complex programs with multiple indications... ...stage through BLA submission. May serve in dual-role... ...aspirations and update senior management on project risks/...SeniorHourly payTemporary workWorldwideFlexible hours3 days per week$258k - $320k
...strategic partner for global clinical development. Our... ...the global CMC regulatory strategy and execution... ...dossier preparation and submissions, and responses to the... ...facilitate the progress of programs in all phases of development... ..., etc.). Lead and manage a team of CMC...SeniorWork at officeWorldwideRelocation package- ...Genentech, located in South San Francisco, seeks a Senior Data Product Manager for Analytical Data Products. You will define product vision, lead cross-functional squads, and deliver scalable data solutions that drive measurable business value. The role reports to the...Senior
- Xaira Therapeutics, Inc. in the San Francisco Bay Area is seeking a Senior Manager, Projects and Programs - Research to lead planning and coordination of biologics programs from discovery through IND-enabling studies. This role is ideal for a scientist who has moved into...Senior
$280.4k - $316.5k
...Senior Director, Translational Medicine and Clinical Biomarkers Own the translational... ...concurrent programs (not a single franchise... ..., research, regulatory, and external collaborators... .... Directly manage and develop at... ...and regulatory submissions. Extensive technical...SeniorFull timeLocal area$140k - $180k
...turns complex hardware designs into safe, high-quality products that can be manufactured reliably at scale.As the Senior/Staff Technical Program Manager for Manufacturing Strategy & Operations, you will serve as a strategic partner to the Director and leadership team....SeniorLocal areaShift work$120k - $150k
Sr Program Manager, Compliance & Salesforce Governance(Hybrid in South San Francisco)SummaryTwist Bioscience is seeking a Senior Program Manager to lead IT Governance, Risk & Compliance (GRC), SOX control framework design, and technology governance across the enterprise...Senior- ...recruiting a Director / Senior Director of Clinical Operations to orchestrate and manage our first clinical... ...dysfunction. Our early stage programs have similar... ...cross-border logistics, regulatory compliance, and... ...member Support regulatory submissions and ongoing global...Senior
- ...The TMF Senior Manager, Clinical Operations serves as the operational leader responsible for the strategy... ...Operations, Quality Assurance, Regulatory Affairs, Clinical Science, Biometrics... ...matter expert across multiple clinical programs, including early-phase, Phase 2, and...Senior
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