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
- ...Vice President, Clinical Services About the Company Tech-enabled homecare company focused... ...into scalable, standardized clinical operating models. The successful candidate will... ...operational complexity. Functions Medical Care/Hospital Administration...OperationsMedical
Confidential
Oakland, CA18 hours ago $354.3k - $377k
...Vice President, Medical Affairs-Neuroscience San Francisco Bay Area At Annexon... ...advancing a late-stage clinical platform of novel therapies... ...: Medical Affairs Operations – focused on communication... ...in clinical development, regulatory affairs, safety, operations...OperationsMedicalLocal areaRemote workFlexible hoursAnnexon Biosciences
San Francisco, CA4 days ago- ...Vice President, Senior Care Clinics About the Company Progressive hospital & healthcare network... ...California Sacramento Kings General Medical Surgical Hospitals Medical... ...strategic leadership, integration, and operational management of clinics serving the...OperationsMedical
- ...Vice President of Regulatory Affairs About the Company A pioneering medical device company developing first-in-class technologies for critical unmet clinical needs. Industry Medical Devices... ...and timelines. Functions ~ Operations...Operations
Confidential
San Francisco, CA18 hours ago $336k - $405k
Reporting to the Chief Medical Officer (CMO), Vice President, Clinical Development provides executive leadership... ...’s product development and regulatory objectives. The Vice... ...closely with Biometrics, Clinical Operations, Regulatory Affairs, Medical Affairs, and Drug Safety...OperationsMedical- ...Vice President of Clinical Operations About the Company Clinical-stage biotechnology company developing differentiated therapies for immune-mediated... .... A relevant advanced degree in a scientific or medical field is also a key requirement. Functions ~...OperationsMedical
Confidential
San Francisco, CA18 hours ago $136k - $192.5k
...SUMMARY/JOB PURPOSE The Clinical Trials Manager (CTM), Clinical Operations, coordinates the activities associated... ...with relevant departments (e.g., Regulatory Affairs, Drug Safety, Clinical Supplies,... ...understand technical, scientific, and medical information Demonstrated success...OperationsMedicalContract workLocal areaFlexible hoursDormont Manufacturing Company
Alameda, CA1 day ago$265k - $331k
...Medicines is a late‑stage clinical oncology company... ...ensures compliance with regulatory requirements, industry... ...continuous improvement and operational excellence. Provide... ..., Regulatory Affairs, and Pharmacovigilance... ...disability, marital status, medical condition, and veteran...OperationsMedicalFull timeContract work$200k - $235k
...application process. Director, Regulatory Affairs - CMC Full Time... ...disease with significant unmet medical need as well as a pipeline... ...regulatory strategies for clinical-stage gene therapy programs... ...functionally with CMC, Technical Operations, Quality, and Clinical...OperationsMedicalFull time$114k - $228k
...and products in diagnostics, medical devices, nutritionals and... ...sensing technology. This Regulatory Affairs Manager position is an onsite... ...‑functionally with R&D, clinical, quality, and commercial teams... ..., scientific affairs, operations, or related area. Higher education...OperationsMedicalWork experience placement- ...Vice President, Pharmacovigilance and Safety About the Company... ...standards of patient safety and regulatory compliance, leading the safety... ...the VP will work closely with clinical development, clinical operations, regulatory, medical affairs, and commercial teams to...OperationsMedical
Confidential
San Francisco, CA1 day ago $100k - $200k
## Principle Regulatory Affairs Specialist - Diabetes Care (on-site)Applylocations... ...products in diagnostics, medical devices, nutritionals and... ...Quality Systems standards, clinical investigations, ICH... ...**JOB FAMILY:**Regulatory Operations## **DIVISION:**ADC Diabetes Care##...OperationsMedicalWorldwideShift work- ...location. Our team of medical clinicians, roboticists... ...’s first remotely-operated, semi-autonomous endovascular... ...Role You’ll own the regulatory strategy and FDA-... ...the CEO, engineering, clinical operations, and quality... ...+ years in regulatory affairs at medical device companies...OperationsMedicalPermanent employmentRemote work
Remedy Robotics
San Francisco, CA2 days ago $40 - $45 per hour
...Job Title: Regulatory Affairs Associate Location: Alameda, CA Work Arrangement... ...of experience in a regulated industry (Medical Device, Pharmaceutical, Nutrition, or... ...Quality, R&D, Scientific Affairs, or Operations experience will also be considered....OperationsMedicalHourly payExperis/Manpower Group
Alameda, CA1 day ago- ...Divisional Vice President of Medicine About the Company Premier provider of specialty... ...of Medicine to spearhead the medical operations strategy for its West Division. The successful... ...for overseeing and directing clinical quality, medical excellence, team-based...OperationsMedicalInternshipLocal area
- ...Vice President, Clinical Development About the Company Established organization... ...to lead the strategic and operational aspects of clinical... ...ensuring compliance with regulatory requirements. This role... ...Manager Title Chief Medical Officer Functions...Medical
Confidential
San Francisco, CA3 days ago - ...Camino Health is seeking a Vice President, Product Design Quality to lead... ...world-class design quality operation ensuring compliance and innovative growth in medical solutions. The ideal... ...quality and strong expertise in regulatory affairs. Apply today to shape the future...OperationsMedicalRemote job
- ...Vice President, Clinical Development (Cardiology) About the Company Clinical... ...protocol development, and regulatory interactions.... ...the company should have a Medical Degree, with board certification... ...leader who is comfortable operating in ambiguity, can help design...Medical
$300k - $420k
...This clinical-stage biotechnology company is changing the treatment of cancer... ...platform. They are seeking a Senior Vice President of Regulatory Affairs to oversee all regulatory activities... ...recommendations. Drive a proactive regulatory operating rhythm across programs (decision...Local areaRelocationFlexible hours3 days per weekDennis Partners
San Francisco, CA1 day ago$114k - $228k
...products in diagnostics, medical devices, nutritionals and... ...manager to join our Public Affairs team in Alameda, CA. The... ...product launches/filings, key clinical and real-world data,... ...various stakeholders including regulatory affairs, operations, quality, R&D, HR,...OperationsMedicalFull timeWork at officeShift work- CLINICAL DATA MANAGER job at cGxPServe. San Francisco, CA. Responsibilities... ...Programming, Clinical Operations, Clinical Research, Quality... ...and Risk Management, and Regulatory Affairs; CROs, central and local... ...using standardized medical terminology, including MedDRA...OperationsMedicalLocal areaFlexible hours
- ...of the most pressing medical challenges of our... ...The Senior Associate, Regulatory Affairs will be a key individual... ...directly to the Vice President, Head of Regulatory... ...supporting regulatory operations, and keeping the... ...cross‑functionally with Clinical Development, CMC,...OperationsMedicalFlexible hours
- ...Clinical Coordinator The Clinical Coordinator is responsible for... ...assisting with management and operation of clinic. This position... ...governing body, Regional Director, Medical Director and the staff as... ...patients, and the operational affairs of the center if delegated by...OperationsMedicalWork at officeLocal area
$114k - $228k
...dream of. Employees can qualify for free medical coverage in our Health Investment Plan... ...and scientists. The Opportunity This Regulatory Affairs Manager - APAC position will work on‑... .../support, scientific affairs, operations, or related area. Strong verbal and written...OperationsMedical$240k - $275k
Position Summary The Director, Clinical Regulatory Affairs serves as a senior regulatory leader responsible... ...partners closely with Clinical Operations, Clinical Development, Safety, and CMC... ...survey data. Benefits Health Insurance (Medical/Dental/Vision) Disability Insurance...OperationsMedicalLocal area- ...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
Oakland, CA18 hours ago - Clinical Trial Manager, Oncology, (Bilingual Asian) Northern New Jersey or San Francisco... ...Clinical Trial Manager to lead the operational execution of global oncology... ...Development, Data Management, Biostatistics, Regulatory Affairs, Medical Affairs, and external partners to...OperationsMedical3 days per week
$150k - $185k
...exciting opportunity for a Sr. Regulatory Affairs Specialist on the... ...planning and delivery of global clinical submissions, assists with the... ...which include Clinical Operations, Clinical Development, Safety... ...experience handling drugs or medical devices. Demonstrated...OperationsMedicalLocal area$191k - $238.8k
...Vice President, External Affairs and Strategic Communications Tides Tides, a nonprofit and philanthropic organization dedicated to advancing... ...offers a generous benefits package including: comprehensive medical, dental and vision insurance, paid time off, life and...MedicalRemote workShift workTides
San Francisco, CA5 days ago- ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage biotech company Industry Biotechnology Type... ...Manager Title Chief Scientific Officer Functions ~ Medical Care/Hospital Administration...Medical
Confidential
San Francisco, CA18 hours ago
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!
- vice president of operations Oakland, CA
- vp of strategy Oakland, CA
- vice president of recruiting Oakland, CA
- vice president of customer success Oakland, CA
- vice president research Oakland, CA
- vice president innovation Oakland, CA
- vice president risk management Oakland, CA
- vp procurement Oakland, CA
- vice president fp&a Oakland, CA
- vice president manufacturing operations Oakland, CA