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 3 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- ...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 (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
$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, CA1 day ago- The Vice President of Operations is responsible for the overall operational success... ...Leadership Team, senior medical leaders, administrative teams... ...initiatives to optimize clinical quality, patient access,... ...compliance with safety, HIPAA, and regulatory policies; monitor quality...OperationsMedical
- ...manufacturing globally. Role Overview CreateMe is seeking a Vice President, People & Business Operations to serve as a strategic and operational partner to the... ...Stay healthy and happy through our comprehensive medical, dental and vision plans, life and disability coverage...OperationsMedicalHourly payContract workRelocation packageFlexible hours
- ...A Clinic Supervisor at Client oversees daily operations across multi-specialty or behavioral health clinics. Responsibilities include supervising medical and dental support staff, managing staff schedules... ...also ensure compliance with regulatory standards and optimize...OperationsMedical
Compunnel
Fremont, CA1 day ago - Calyxo, Inc. is a medical device company headquartered in Pleasanton, California... ...are seeking an accomplished Staff Regulatory Affairs Specialist to serve as a senior... ...closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and...OperationsMedicalWork at officeWorldwideShift work3 days per week
- ...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, CA11 hours ago $283.5k - $354.38k
...decision-making for all Pharmacy Operations and Services in the Northern... ...in the region (KFH/HP and Medical Group), ensuring that... ...technology, quality processes, regulatory compliance and drug use management... ...region pharmacies and clinical pharmacy programs. Directly...OperationsMedicalFull timeWork experience placementLocal areaWork from homeFlexible hoursShift workKaiser Permanente
Pleasanton, CA4 days ago$120.1k
...Overview: Natera, Inc. is a clinical genetic testing... ...tube of blood. Natera operates CAP-accredited laboratories... ...business development, regulatory, engineering, design,... ...team, regulatory affairs, customer operations,... ...include comprehensive medical, dental, vision, life...OperationsMedicalWork at officeLocal areaImmediate startRemote workWorldwideShift workGrabJobs
Fremont, CA4 days ago$23 - $76 per hour
...Compliance Program, including following all regulatory and FMS policy requirements. Ensure... ...while maintaining cost-effective clinical operations in accordance with all legal,... ...associated with dialysis. Administer medications to patients per physician's orders....OperationsMedicalHourly payTemporary workWork experience placementShift workFresenius Medical Care
Fremont, CA4 days ago- ...The Senior Clinical Research Associate (Sr. CRA) is a high... ...responsible for the day-to-day operational integrity of XII Medical’s clinical studies.... ...Master File stewardship, regulatory and ethics authority interactions... ...clinical and medical affairs teams. Ensure all safety...OperationsMedicalInterim roleWork at officeLocal area3 days per week
XII Medical
Union City, CA4 days ago - ...Care, Inc. in Union City is seeking a Certified Medical Assistant for a part-time role that involves both clinical and front desk duties. This position includes rooming... ...-of-care testing, and ensuring smooth clinic operations. Your contribution will greatly enhance patient...OperationsMedicalPart timeWork at office
American Family Care
Union City, CA23 hours ago - ...Clinical Procurement Analyst (Site Payments/Budgets) - Hybrid Pleasanton, United States... ...Rate: $41.50/hr on W2 Company Benefits: Medical, Dental, Vision, Paid Sick Leave, 401K We... ...compliance, audit readiness, and procurement operations. Job Responsibilities: Review, cleanse,...OperationsMedicalLong term contractFlexible hours
Dawar Consulting
Pleasanton, CA3 days ago $120k - $145k
...Clinical Research Associate 2 Fremont, CA Personalis... ..., Personalis operates one of the largest sequencing... ...provider to Veterans Affairs' Million Veteran... ...Sequencing (NGS) platforms, medical devices, and will... ...operations, monitoring, regulatory, and clinical quality...OperationsMedicalFull timeRemote work$90k - $110k
...Emergency & Specialty practice seeking a Veterinary Clinical Services Supervisor to join our dedicated team. We’... ..., 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 department...OperationsMedicalRelocation packageBeacon Veterinary Specialists
Fremont, CA3 days ago- ...Vice President of Human Resources About the Company Innovative online college providing affordable learning programs for adult learners... ...leadership and strategic guidance for its human resources operations. The successful candidate will be responsible for developing...Operations
Confidential
Fremont, CA1 day 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 $250k - $275k
...Job Summary: Reporting to the COO, this Senior Vice President is responsible for the overall operation of several hundred accounts across Northern California... ...Canteen are offered many fantastic benefits. Medical Dental Vision Life Insurance/ AD...OperationsMedicalContract workTemporary workWork at officeLocal areaRemote workFlexible hoursCompass Group, North America
Hayward, CA6 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, CA23 hours ago$350k
Clinical Psychiatrist Location: Fremont; La Jolla; Laguna Hills... ...Provide ongoing psychiatric medication management as clinically indicated... .... Partner with Clinical Operations and Medical Leadership to... ...standardization of care. Ensure regulatory compliance and safety...OperationsMedicalFull time- ...Calyxo, Inc. is a medical device company headquartered in Pleasanton... ...atmosphere. Summary: The Clinical Project Manager plays a... ...and in full compliance with regulatory requirements. This position... ...settings and have a passion for operational excellence in clinical research...OperationsMedicalContract workShift work
Calyxo USA Inc
Pleasanton, CA11 hours ago - ...Quality Assurance Benefits Medical, Dental, and Vision... ...in Quality and Operations leadership or management... ...is to improve clinical outcomes for high-risk... ...Pleasanton, CA. SUMMARY The Vice President of Global Operations... ..., direct reps, regulatory and other department...OperationsMedicalContract workWorldwide
- Reporting to the COO, this Senior Vice President is responsible for the overall operation of several hundred accounts across Northern California. The role involves... ...required; occasional non‑local travel. Benefits Medical Vision Life Insurance/AD Disability Insurance...OperationsMedicalContract workTemporary workWork at officeLocal areaFlexible hours
- ...Calyxo, Inc. is a medical device company headquartered in Pleasanton,... ...atmosphere. Summary The Senior Clinical Research Associate (Senior CRA) provides operational leadership, oversight, and mentorship... ..., effective site management, regulatory compliance, and audit readiness...OperationsMedicalFull timeWork at officeRemote workShift work3 days per week
Calyxo USA Inc
Pleasanton, CA1 day ago $123.89k
...Clinical Laboratory Associate (CLA), Prenatal (Overnight Shift) Join a team of brilliant... ...from some of life's most critical medical moments. If you're driven by purpose,... ...responsible for assisting our day-to-day operations, providing equipment maintenance in the...OperationsMedicalHourly payLocal areaWorldwideShift workNight shiftWeekend workDay shiftWeekday work$48.14 - $65 per hour
...Clinical Dietitian Salary Range: $48.14 - $65.00 + applicable differentials Division: Operations and Support Job Title: Clinical Dietitian -... ...health care team to provide medical nutrition therapy that... ...Commissionand/or other regulatory standards; maintaining professional...OperationsMedicalDaily paidWork experience placement$157.02k - $207.27k
...homes and communities by providing comprehensive medical care and community-based services. Under the direction of the Clinical Nurse Director (CND), the Clinical Nurse Manager organizes and directs the day-to-day operations within the clinic, oversees clinic staff, and...OperationsMedicalMonday to FridayWelbeHealth
Fremont, CA8 days ago- Overview The Regional Clinical Director (RCD) provides strategic... ...leadership, clinical oversight, and operational management across multiple... ...meeting all contractual, regulatory, and ethical standards. The... ..., breastfeeding status, medical condition, genetic information...OperationsMedicalFull timeWork at officeLocal areaTrial periodFlexible hoursAfternoon shift
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
- vp of strategy Fremont, CA
- vice president of recruiting Fremont, CA
- vice president of customer success Fremont, CA
- vice president research Fremont, CA
- vice president innovation Fremont, CA
- vice president risk management Fremont, CA
- vp procurement Fremont, CA
- vice president business solutions Fremont, CA
- vice president fp&a Fremont, CA
- vice president design Fremont, CA