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 of Regulatory Affairs About the Company Well-funded clinical-stage biotech developing a retina-focused ophthalmology therapeutic.... ...leadership opportunity. Hiring Manager Title Chief Medical Officer Functions ~ Operations ConfidentialOperationsMedical
- ...advancing a late-stage clinical platform of novel... ...join our team as Vice President, Clinical... ...include: Lead the medical/clinical oversight... ...with the Medical Affairs team, review and... ...study reports, and regulatory communications... ...collaboration with Clinical Operations, oversee the...OperationsMedical
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Dispatch Bio
San Francisco, CA5 days ago - Overview Senior Director, Regulatory Affairs - Permanent - San Francisco,... ...for a growing and exciting clinical-stage biotechnology company... ...global regulatory strategy and operations across the company’s... ...biopharmaceutical, biotechnology and medical device companies....OperationsPermanent employment
- ...Vice President, Clinical Services About the Company Top telehealth weight loss program... ...responsible for leading and scaling clinical operations across a large, distributed practice,... ...COO Functions Medical Care/Hospital Administration Operations...OperationsMedical
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San Francisco, CA4 days ago - ...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
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San Francisco, CA5 days ago $114k - $228k
...and products in diagnostics, medical devices, nutritionals and... ...new sensing technology. This Regulatory Affairs Manager position is an... ...cross-functionally with R&D, clinical, quality, and commercial teams... ..., scientific affairs, operations, or related area. Note: Higher...OperationsMedicalShift work$425k
...SHSO-Administrative PayrollPosition Overview:The Vice President, Direct‑to‑Employer (DTE) Business is a senior enterprise... ...and on‑site services). In close partnership with clinical operations, service line leaders, and the medical group, the VP ensures solutions are clinically...OperationsMedicalFull timeContract workShift work$330k - $375k
...vision and strategy for clinical supply operations and launch and commercialization... ...to address unmet medical needs. Essential Duties... ...Management, Program Management, Regulatory Affairs, and Quality. Supports... ...the base salary for the Vice President, Clinical Supply...OperationsMedicalContract workLocal areaWorldwideInternational Executive Service Corps
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Alameda, CA2 days ago - ...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
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- ...Vice President, Pharmacovigilance and Safety About the Company Forward... ...of patient safety and regulatory compliance, leading the safety... ...VP will work closely with clinical development, clinical operations, regulatory, medical affairs, and commercial teams to integrate...OperationsMedical
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...businesses and products in diagnostics, medical devices, nutritionals and branded... ..., and scientists.The Opportunity This Regulatory Affairs Manager - APAC position will work on-site... ...development/support, scientific affairs, operations, or related area.Strong verbal and...OperationsMedicalShift work$200k - $250k
...with significant unmet medical need as well as a pipeline... ...Reporting to the Chief Regulatory Officer, the Director, Regulatory Affairs CMC will serve as a key... ...strategies for clinical-stage gene therapy programs... ...functionally with CMC, Technical Operations, Quality, and Clinical...OperationsMedicalRay Therapeutics, Inc.
San Francisco, CA4 days ago- ...Vice President, Clinical Operations About the Company Innovative company designing & developing gene therapeutic products Industry Biotechnology Type Public Company Founded 2013 Employees 51-200 Categories Biotechnology...Operations
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Emeryville, CA3 days ago $148.7k - $297.3k
...businesses and products in diagnostics, medical devices, nutritionals and branded... ...The Opportunity This Associate Director Regulatory Affairs will work on-site out of our Alameda,... ...development/support, scientific affairs, operations, or related area. Note: Higher...OperationsMedicalWorldwideShift work$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 areaInternational Executive Service Corps
San Francisco, CA1 day ago- ...worldwide, dedicated to advancing medical education through innovative... ...with access to the latest clinical knowledge and surgical... ...and Zagreb, Croatia. As the Vice President of Sales at Vumedi, you will... ...and service offerings. Sales Operations: Oversee all aspects of the...OperationsMedicalWorldwide
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$216k - $241k
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...Care Medicine, Department of Pediatrics Clinical X or HS Clinical Faculty SeriesThe... ...qualified Associate Chief for Clinical Operations. The appointment will be made at the Associate... ...candidate will join a leading academic medical center with an established fellowship training...OperationsMedical$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- ...client is an early‑stage, biotech operating in stealth mode. This is a... ...floor and shape both the regulatory function and broader development... ...for a Head of Regulatory Affairs (VP/SVP) who can build the regulatory... ...cross‑functionally with Clinical Development, CMC, Nonclinical...
$129.6k - $192.39k
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Oakland, CA4 days ago$104.77k - $130.67k
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Oakland, CA6 hours 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
Oakland, CA5 days ago
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