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- 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
- ...located in Brisbane, CA, is seeking a Senior Manager, Regulatory Operations to join the Regulatory Affairs team. You will coordinate submissions in Veeva RIMS, compile documents for US... ...ensure regulatory compliance across programs. The ideal candidate has 5+ years in Regulatory...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$140k - $214k
...BAFF and APRIL may prove clinically meaningful. Vera Therapeutics... ...Summary:Vera is seeking a Senior Manager, Regulatory CMC to join an experienced... ...and support regulatory submissions and activities in the US and... ...to support development programs.Responsibilities:Proactively...SeniorContract workFor contractorsFlexible hours- Kite Pharma is seeking a Clinical Operations Team Leader in San Francisco, California. This role is crucial for overseeing the successful... ...will have a background in clinical operations, experience managing teams, and strong interpersonal skills. The position offers a competitive...Senior
- Job Title: Senior Program Director - Commercial Regulatory Affairs (Advertising & Promotion) Employment Type: Contract on W2 Workplace Type... ...for commercial product launches Prepare and manage FDA promotional submissions, including Form FDA 2253 Support product labeling...SeniorContract work
$5,000 per month
...independent lives. Our comprehensive programs empower foster youth to... ....POSITION SUMMARY: The Clinical Manager is an energetic,... ...participant records including timely submission of all utilization,... ...policies and protocols and all regulatory requirements.Work with referral...Full timeCasual workWork at officeLocal areaTrial periodVisa sponsorshipWork visaRelocation packageFlexible hoursAfternoon shift2 days per week3 days per week$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- ...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
- ...progressing multiple programs through partnership,... ...Reporting to the Director, Regulatory Affairs Project Management and Operations, the Senior Manager, Regulatory... ...of regulatory submissions in Veeva RIMS and documents... ...(e.g. Regulatory, Clinical, Nonclinical, Clinical...Senior
$230k - $270k
...South San Francisco, is a clinical-stage biotechnology... ...autoimmune disease. Led by a management team with significant... ...a talented, motivated Senior Director to join our Portfolio & Program Management Team as a... ...from Research, Clinical, Regulatory, Ops Tech, and...SeniorFull timeLocal areaRemote work$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$260k - $365k
Structure Therapeutics Inc. seeks a Senior Director, Medical Director to spearhead the medical strategy for obesity and metabolic diseases... ..., leading publication strategies, and ensuring compliance with regulatory standards. Candidates should possess an MD, PharmD, or PhD with...SeniorRemote work$230k - $270k
Allogene Therapeutics is seeking a Senior Director to lead the Portfolio & Program Management Team in South San Francisco. This role involves managing a cross-functional team to drive execution of key programs in the biotech space. Required qualifications include a Bachelor...Senior- 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...
- ...employment. Position: Senior Manager / Associate Director, Regulatory Affairs Location: South... ...team. This role spans both Clinical and CMC (Chemistry,... ...advancing our clinical programs toward market approval.... ...high-quality regulatory submissions, including INDs, CTAs, meeting...SeniorWork at officeShift work
- ...Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials. The... ...ensuring regulatory compliance, and coordinating global submissions. The ideal candidate will have 5+ years in biotech/...Senior
- 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
- ...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, 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
- ...in South San Francisco, seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls... ...lead regulatory strategies and submissions for our US and global programs. The role reports to the... ...BLA/MAA filings for biologics, manage the CMC document control system,...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
$245k - $285k
...responsible for leading and managing the regulatory affairs within CMC... ...assists corporate senior management in... ...development and exposure to clinical regulatory strategy... ...of regulatory CMC submissions including type B, C,... ...into development programs and that products are...SeniorContract work$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- ...Therapeutics is seeking an Oversight Director, Clinical Operations to provide strategic and operational leadership across CKD and PKU programs. You will guide the Clinical Development... ...trial execution with budget and risk management. You will develop Study Leads and manage...Senior
$175k - $205k
...Sr Manager/Assoc Director, CMC Regulatory Affairs San Diego, CA, South San Francisco... ...remote Erascais a clinical-stage precision... ...with cancer. Our programs take novel approaches... ...Affairs, the Senior Manager or Associate... ...through QC review of submission components, including...SeniorTemporary workCasual workLocal areaRemote workWorldwideFlexible hours$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
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