Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs
Confidential
Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs
About the Company
An innovative, patient-focused biotechnology company.
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is in search of a Vice President for Regulatory Affairs, Clinical Operations, and Medical Affairs. This executive leadership role is pivotal in driving the strategic development and execution of global regulatory strategies for product development, clinical studies, manufacturing changes, and commercialization. The successful candidate will be responsible for leading the preparation and maintenance of various regulatory submissions, serving as the primary liaison with regulatory agencies, and providing guidance to executive leadership. Additionally, the role involves overseeing clinical trial planning, execution, and ensuring compliance with GCP, ICH guidelines, and other global regulatory requirements. The Vice President will also lead medical affairs functions, including building strategic partnerships with Key Opinion Leaders, guiding scientific communications, and supporting evidence generation and post-marketing activities. Applicants for the Vice President position at the company should hold an advanced degree, with a medical degree being preferred, and have a minimum of 15 years' progressive leadership experience in the biotechnology, pharmaceuticals, or related fields. A minimum of 10 years' in regulatory affairs leadership is required, along with significant experience in overseeing clinical operations and medical affairs. The ideal candidate will have a proven track record in regulatory submissions, agency interactions, and supporting products through commercialization, as well as expert knowledge of FDA regulations, ICH guidelines, GCP, GMP, and global regulatory requirements. The role demands a leader with the ability to drive organizational growth, lead cross-functional teams, and operate effectively in a fast-paced, highly regulated environment.
Functions
- Operations
- Medical Care/Hospital Administration
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs in Fremont, CA vacancy
$360k
...patients with significant unmet medical needs. By combining... ...Medical Officer, the Vice President, Clinical Development will play a critical... ...closely with Medical Affairs, Clinical Operations, Biostatistics, Safety/Pharmacovigilance, Regulatory Affairs, Translational Medicine...OperationsMedicalFull timeWork at officeFlexible hours2 days per week$90k - $180k
...Type: Full timeCategory: Regulatory AffairsIndustry:... ...products in diagnostics, medical devices, nutritionals... ...by delivering seamless clinical solutions from diagnosis... ...a Senior Regulatory Affairs Specialist to join our... ...requirements, company policies, operating procedures, processes,...OperationsMedicalFor contractorsWorldwide$73.9k - $116k
...and products in diagnostics, medical devices, nutritionals and... ...health by delivering seamless clinical solutions from diagnosis to... ...monitoring and treatment. This Regulatory Affairs Specialist will work out of... ..., Company policies, operating procedures, processes, and task...OperationsMedicalWork experience placementAbbott
Pleasanton, CA2 days ago$86.7k - $102k
.... Advanced technology, a world-class clinical development organization, and state-of... ...to achieve impactful results. The Regulatory Affairs Operations team creates and manages investigational... ...in addition to a full range of medical, financial, and/or other benefits (including...OperationsMedicalLocal areaTAIHO ONCOLOGY INC
Pleasanton, CA4 days ago- ...Executive Director, Regulatory Affairs About the Company Esteemed company developing medicines for inflammatory & autoimmune diseases... ...Director for Regulatory Affairs to provide strategic and operational leadership across its cell therapy portfolio. The...Operations
Confidential
Fremont, CA2 days ago - ...Santa Clara and Santa Cruz. A Day in the Life: The Vice President of Operational Strategywill serve as a senior strategic leader responsible... ...site presence required based on operational needs. ~100% medical, dental and vision benefits for employees and agency...OperationsMedicalPermanent employmentContract workWork at officeRemote workFlexible hours
Abode Services
Fremont, CA2 days ago - ...Responsibilities Lead the Medical Affairs and Clinical Affairs teams Develop and manage laboratory professionals and Medical Affairs team... ...healthcare environment Experience in clinical trial design, operations, and execution Experience managing clinical flow...OperationsMedicalRemote work
Jobtailor
Milpitas, CA4 days ago $285k - $370k
...commercially deployed humanoids operate alongside teams in... ...fulfilling. Role Overview The Vice President, Corporate Controller will serve... ...with SEC, Nasdaq, and other regulatory requirements. Implement public... ...Coverage: 100% company-paid medical, dental, vision, and short/...OperationsMedicalFull timeTemporary workRelocation packageFlexible hoursDoist
Fremont, CA3 days ago- Responsibilities: The Clinical Coordinator is responsible for assisting with management and operation of clinic. This position assumes... ...governing body, Regional Director, Medical Director and the staff as... ..., and the operational affairs of the center if delegated by...OperationsMedicalWork at officeLocal area
Satellite Healthcare, Inc
Milpitas, CA16 hours ago - ...Job Description Calyxo, Inc. is a medical device company headquartered in Pleasanton... ...are seeking an experienced Senior Regulatory Affairs Specialist to support our growing... ...with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and...OperationsMedicalWork at officeWorldwideShift work
- ...markets, Health Plans, Permanente Medical Group (PMG), and Medical Centers leaders for clinical pharmacy and quality programs;... ...to ensure they comply with regulatory standards (e.g., Medicare, National... ...support markets and pharmacy operations, escalating concerns when necessary...OperationsMedical
- ...Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub... ...an expert in ophthalmic and medical device research who is a core... ...coordinating with Clinical Operations and Project Management... ...Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure...OperationsMedicalFull timeWork experience placementLocal areaImmediate start
- ...Canteen. Job Summary: Reporting to the COO, this Senior Vice President is responsible for the overall operation of several hundred accounts across Northern... ...Associates at Canteen are offered many fantastic benefits. Medical Vision Life Insurance/ AD Disability Insurance...OperationsMedicalContract workTemporary workWork at officeLocal areaFlexible hours
Compass Group USA
Hayward, CA4 days ago - ...with multiple functions (Operations, R&D, Sales &... ...consultants who contribute to regulatory submissions, ensuring... .... Regulatory Affairs: Lead and develop a Regulatory... ...Moximed’s applicable clinical trials (ACT) on clinicaltrials... ...processing of Moximed Medical Device Reports (MDRs)...OperationsFlexible hours
Moximed
Fremont, CA4 days ago $125k - $201.25k
...Function: Discovery & Pre-Clinical/Clinical... ...in ophthalmology and medical device research. This... ...monitoring, reporting and regulatory submission of clinical... .... Align with Clinical Operations team (study managers,... ...Regulation, Regulatory Affairs Management, Relationship...OperationsMedicalFull timeWork experience placementLocal areaImmediate start$90k - $180k
...Type: Full timeCategory: Regulatory AffairsIndustry:... ...products in diagnostics, medical devices, nutritionals... ...by delivering seamless clinical solutions from diagnosis... ...Senior Regulatory Affairs Specialist will work out... ...requirements, Company policies, operating procedures, processes,...OperationsMedicalFor contractorsWork experience placementWork at office- ...Community Health Worker Team: Mobile Health Operations Be the trusted face that turns a parking... ...and made it feel possible. At Mission Mobile Medical, our Community Health Workers are the bridge between the clinic on wheels and the community it serves—driving...OperationsMedicalWork at officeFlexible hoursAfternoon shift
Mission Mobile Medical
Fremont, CA7 days ago $230k
...Pharmaceutical Holdings Limited , is a clinical-stage biotechnology company... ...acute treatment of serious medical conditions—where rapid... ...treated. Job Summary Manage all regulatory activities for the company.... ...industry with direct regulatory affairs experience with drug products...MedicalNova Pneuma, Inc.
Fremont, CA1 day ago- ...invite you to join our team as a Clinical Laboratory Technician -a... ...and safe, complying with all regulatory and accreditation demands.... ...Bachelor's degree in Clinical or Medical Laboratory Science, or a... ...resulting in a more sustainable operation. Grateful patient feedback not...OperationsMedicalFull timeLocal areaWeekend workAfternoon shift
MLee Medical Employment
Fremont, CA3 days ago $90k - $110k
...Veterinary Clinical Services Supervisor Beacon Veterinary Specialists is a criticalist-led 24/7 Emergency &... ...Supervisor, you'll be responsible for overseeing the daily operations of the client service and veterinary medical support team. You'll set the tone for the...OperationsMedicalRelocation package- ...Job Description Job Description Medical Assistant Team: Mobile Health Operations Bring healthcare to the doorsteps that need it most. Imagine being the calm, capable hands that make a mobile clinic visit feel like real care—not just a stop on a route. At Mission...OperationsMedicalWork at officeLocal areaFlexible hoursAfternoon shift
Mission Mobile Medical
Fremont, CA7 days ago - ...hiring a Senior Staff Clinical Quality Associate for... ...compliance governance, and regulatory readiness across... ...services, documentation, and operations align with applicable... ...in medical device, pharmaceutical... ...Auditor (CQA), Regulatory Affairs Certification (RAC), or...OperationsFull timeFor contractors
$86k - $105k
...Clinical Trial Associate Ardelyx is a commercial-stage biopharmaceutical... ...with significant unmet medical needs. By combining... ...assigned clinical trials, ensuring operational excellence, compliance with ICH-GCP and applicable regulatory requirements, and adherence to...OperationsMedicalFull timeWork at office- Title: Vice President of Products Company: Mattson Technology, Inc., a 38-year Silicon Valley company, designs, manufactures, markets, and... ...Technology, with its Silicon Valley DNA, will continue to operate as a global, market-driven technology provider serving worldwide...OperationsWorldwide
- ...oversee the administration and clinical direction of all dialysis... ...will work closely with our Medical Directors to plan, organize,... ...services, ensuring compliance with regulatory standards and best practices... ...and Planning : Manage operational and capital budgets,...OperationsMedicalRelocation package
University Health
Fremont, CA4 days ago - ...Executive Medical Director About the Company Small, agile development team... ...-phase immunology and inflammation clinical programs. Industry... ...external stakeholders, including clinical operations, biometrics, regulatory, pharmacovigilance, and translational...OperationsMedicalRemote workFlexible hours
Confidential
Fremont, CA1 day ago $75.21 - $100.96 per hour
...Clinical Pharmacist Lead The Clinical Pharmacist Lead is responsible... ...for overseeing the daily operations of the pharmacy department,... ...safe and effective use of medications, and providing leadership to... ...and ensuring compliance with regulatory standards. The Clinical...OperationsMedicalHourly payLocal areaStanford Health Care Tri-valley
Pleasanton, CA3 days ago$275k - $330k
...continues to grow through both organic expansion and acquisitions, operational complexity is increasing, creating the need for greater... ...enterprise.Reporting to the Chief Operating Officer, the Vice President, Operational Excellence & Transformation leads Nextpower's Operational...OperationsWork at officeWorldwide- ...COMPANY OVERVIEWMeraqi Medical, now a part of Viant... ...development, as well as clinical and commercial... ...our customers and on operational excellence. With nearly... ...ensuring product quality, regulatory compliance, manufacturability... ..., Quality, Regulatory Affairs, Supply Chain, and...OperationsMedicalContract workWorldwide
- ...measurable improvements and close operational gaps.Oversee enterprise emergency management... ...working groups established in clinical, facilities, external affairs, community affairs, forward... ...objectives. Supports and consults to medical centers and regions to maintain their...OperationsMedicalContract workWork experience placementWork at officeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs. Be the first to apply!
Related searches
- vice president education Fremont, CA
- vice president manufacturing Fremont, CA
- vice president Fremont, CA
- vice president supply chain Fremont, CA
- vp biotech Fremont, CA
- vice president event Fremont, CA
- vp talent acquisition Fremont, CA
- vice president healthcare Fremont, CA
- vice president finance Fremont, CA
- vp risk management Fremont, CA