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
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...care. We are looking for a Regional Clinical Manager (NP) to lead a dynamic and high... .... * Competitive Pay * Comprehensive Medical, Dental, & Vision * PTO * Strong Work... ...* Proven experience managing day-to-day operations, schedules, mentoring/training, maintaining...OperationsMedicalLocal areaJobot
Sacramento, CA6 hours ago$57 - $67 per hour
Department: Medical Management - Pharmacy Status: Non - Exempt Schedule: Up... ...Health Advantage Make an Impact Where Clinical Excellence Meets Managed Care... ...the intersection of clinical rigor, regulatory compliance, and operational excellence. This position primarily...OperationsMedicalHourly payWork experience placement$350k - $375k
...Reporting to the President of FUJIFILM Holdings... ...Team, the Vice President, General... ...dynamics and the regulatory environment that spans... ...framework for the legal affairs for FUJIFILM... ...Legal Department operations. Responsible for legal... ...the life sciences, medical device, or biotechnology...OperationsMedicalWork at officeFUJIFILM Corporation
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...with the Senior Director of Clinical Management, the Director is responsible for the operational strategy and management of clinical... ...of clinical sections of regulatory documents (i.e., Investigators... .... • Serves as contact for Medical Affairs/PBS related to medical information...OperationsMedicalContract workTemporary workLocal areaFlexible hoursOtsuka America Pharmaceutical Inc.
Sacramento, CA1 day ago$140k - $150k
...mission-first hospice program with a strong clinical foundation and a supportive... ...Opportunity Direct the day-to-day clinical operations of a respected, established hospice program... ...Collaborate across departments including intake, medical directors, and field teams to ensure...OperationsMedicalTemporary workMonday to FridayStrong Force Staffing
Sacramento, CA2 days ago$9.28k - $19.15k
...Executive Director of Therapy Services, and the Medical Director's clinical oversight the Clinical Operations Manager (COM) for Respiratory Care Services (RCS)... ...standards. The COM is responsible for ongoing regulatory compliance and follow up, represents RCS on several...OperationsMedicalDaily paidFull timeContract workTemporary workPart timeLocal areaShift workWeekend workDay shiftUniversity of California- Davis Health
Sacramento, CA1 day ago- ...are seeking an experienced Clinical Research Coordinator (CRC) to... ...Collect and document accurate medical histories and clinical data... ...consent in compliance with regulatory standards Manage study activities... ...within clinical research operations. If you are detail-oriented,...OperationsMedical
- ...Description/Requirements: Our positions of clinical leadership allow you to utilize your... ...registered nurse in the state of agency operation *Shall have at least two (2) years... ...administrative experience *Prior use of Electronic Medical Records (EMR) preferred *Must be a...OperationsMedicalLocal area
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...Program Director - Medical Assistant(No Previous Teaching Exp is... ...planning, development, and daily operations of our program while... ...California Department of Consumer Affairs, ACCSC, BPPE, DOE and Title IV... ...Staff who provide extramural clinical practice. Ensuring extramural...OperationsMedicalFull timePart timeWork experience placementWork at officeUnitek Learning
Sacramento, CA3 days ago- ...come together to advance the state of clinical development. As the world's leading... ...analytical methods. We are seeking a Vice President, Business Development with extensive experience... ...with Project Management, Business Operations, and Business Unit Heads. Foster and...Operations
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...Position Overview The Clinical Specialist Indianapolis, IN position is responsible for... ...of the salary range). ~ Insurance: ~ Medical, Dental & Vision ~ Life & Company paid... ...place an undue hardship on business operations. FUJIFILM Sonosite offers a fantastic...OperationsMedicalRemote workFUJIFILM Corporation
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West Sacramento, CA3 days ago$225k - $300k
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Sacramento, CA2 days ago$22.68 - $30.04 per hour
...Position Information Job Title Clinical Specialist Union Level Department... ...Under the direction of the Admissions and Operations Director and the Clinical Director, this... ...and veteran status, sexual orientation, medical condition, pregnancy, gender identity, gender...OperationsMedicalHourly payFull timePart timeWork at officeAfternoon shiftUniversity of the Pacific
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## Clinical Research Program ManagerApplyremote type: On-Sitelocations: Sacramento, CAtime... ...professional who is responsible for operational management, overseeing all local SC's clinical... ...the Chief of Staff, SC scientific and medical staff and other research personnel to...OperationsMedicalWork at officeLocal area$145k - $180k
...Job Description Job Description Clinical Pharmacy Specialist, Oncology Join our Shields... ...at a nationally recognized Academic Medical Center. In this dynamic, patient‑... ...initiatives. Provide recommendations to operations by supporting teammates as needed with complex...OperationsMedicalHourly payTemporary workWork at officeLocal areaRemote workRelocation packageShields Health Solutions
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Habitat Health | Clinical Services Director (RN) Position: Full‑time. Work Location: Onsite... ...team members. Lead a service‑oriented operation that fosters a sense of belonging and... ...coordinate with clinical, operations, and medical directors. Meet key performance indicators...OperationsMedicalFull timeFlexible hours- ...Description We are seeking an experienced Clinical Resource Nurse, licensed as an RN in... ...strong understanding of CMS and CDPH regulatory requirements, possess the capacity to... ...Conducts on-site reviews of clinical operations, medical records, and staff performance. ·...OperationsMedical
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