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
Irvine, CA4 days ago - ...Independently or under the supervision of the Regulatory Affairs Manager and Assistant Director of Clinical Research Operations, the incumbent is in charge of the regulatory... ...offices and clinics are located at the UCI Medical Center in Orange and the UCI campus in Irvine...OperationsMedicalWork experience placementWork at officeLocal area
University Of California Irvine
Orange, CA12 hours 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
$160k - $170k
...Senior Manager, Clinical Compliance Fully... ...: VP, Clinical Affairs Job Location &... ...Reporting to the Vice President, Clinical Affairs... ...procedure lifecycle, regulatory intelligence, and... ...impact on operations and procedures and... ...quality assurance; medical device experience...OperationsMedicalFull timeContract workWork at officeRemote workHome office- ...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
- ...Vice President, Research Integrity & Compliance About the Company... ...Categories Health Care General Medical Surgical Hospitals... ...Specialties cancer clinical trials neurology geriatric... ...controls, ensuring adherence to regulatory requirements, and guiding...Medical
$2,071 per week
...Registered Nurse (RN) | Outpatient Clinic Location: Orange, CA Agency: Magnet Medical Pay: $2,071 per week... ...flow, and ensuring the smooth operation of the clinic while maintaining... ...in compliance with clinic and regulatory standards, ensuring patient data...OperationsMedicalFull timeContract workImmediate startShift workNight shiftMagnet Medical
Orange, CA3 hours ago- ...Travel Clinical Laboratory Scientist Orange, California Get all the details (no obligation... ...Description We're looking for a Medical Technologist (CLS) for an immediate... ...of laboratory instrumentation, including operation, maintenance, and troubleshooting. Clinical...OperationsMedicalImmediate start
Travel Nurse Across America
Orange, CA2 days ago - ...queries, etc.) Develop and execute device processes associated with clinical trials. Ensure compliance with regulations and manage the... ...facing experience in a clinical research, healthcare, or related medical setting. Current CPR and First Aid certification from an...OperationsMedical
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Irvine, CA1 day ago - Become a Utility Regulatory Affairs Senior Advisor within State Regulatory Operations at Southern California Edison (SCE) and build a better tomorrow. In this job, you... ...data, proprietary information, confidential medical records, and other types of highly sensitive information...OperationsMedicalRemote workRelocation
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$20 per hour
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- ...We are on the lookout for a Clinical Lab Technician who... ...environment while fully adhering to regulatory and accreditation requirements... ...'s degree in Clinical or Medical Laboratory Science, or an equivalent... ...patients and stronger operations. The many notes of...OperationsMedicalFull timeLocal areaImmediate startDay shiftAfternoon shift
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Santa Ana, CA12 hours ago - ...Job Title Supervisor, Clinical Dietitians Work Location... ...Clinical Nutrition and Lactation operations as well as designated... ...parameters of licensure and regulatory requirements, practice requirements... ..., lactation or related medical conditions), gender identity...OperationsMedicalShift work
Choc
Orange, CA3 days ago - ...Travel Clinical Laboratory Scientist (CLS) – Generalist Company: Fusion Medical Staffing Location: Facility in Orange, California... ...in quality control and regulatory compliance, and plays a key... ...facilities, ensuring that laboratory operations meet state and federal...OperationsMedicalTemporary work
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Orange, CA1 day ago $65 - $70 per hour
...Southern California Clinical Research part of Southern California Dermatology clinic in... ...Research. This role involves performing medical assessments, ensuring compliance with study... ..., and our expertise optimizes practice operations and growth. Ready to advance your...OperationsMedicalHourly payFull timeImmediate startRelocationFlexible hoursWest Dermatology
Santa Ana, CA1 day ago$24 - $32 per hour
...Future Opening: Clinical Research Coordinator II Full Time • Garden... ...compliance with all regulatory requirements, maintaining data... ...skills. Job Types Full-Time Medical, Dental, Vision, 401K, PTO and... ...technologies, streamlined clinical operations, and extensive access to a...OperationsMedicalHourly payFull timeWork at officeLocal areaNational Institute of Clinical Research
Garden Grove, CA1 day ago- ...solutions to pharmaceutical companies, medical device companies, biotech... ...consulting staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality... ...manufacturing, validation, and scientific operations. Our dedicated recruitment team...OperationsMedicalContract work
- ...Clinical Laboratory Scientist, Generalist Garden Grove, CA Healthcare Job Title:... ...the accuracy and reliability of data. Operate, calibrate, and maintain equipment and instruments... ...Qualifications: Bachelor's degree in Medical Technology, Clinical Laboratory Science,...OperationsMedicalFull timeNight shift
$35 - $40 per hour
...for coordinating and managing clinical research protocols under the... ...with all institutional and regulatory guidelines. It supports Ark... ...smooth and effective study operations. It involves ongoing evaluation... ...and accurate reporting of medical tests to the PI, and the successful...OperationsMedicalHourly payFull timeThe Voluntary Protection Programs Participants' Association,...
Fountain Valley, CA1 day ago- ...The Clinical Research Assistant will support the research team in conducting clinical... ...Assistant will play a key role in the daily operations of research studies, ensuring protocols... ...instructions (e.g., fasting, bringing medication bottles, etc.). Preparing for study...OperationsMedical
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...Vice President, Learning and Development Job Locations US-CA-Newport Beach | US... ...significant involvement in both property operations and corporate functions. This role designs... ...package that includes a 401(K) match, medical, dental, vision, other voluntary...OperationsMedicalWork at officeSares- Regis Group
Newport Beach, CA6 hours ago$60k - $70k
...welcome! Position Details We are seeking a Clinical Dietitian to deliver exceptional... ...Corporate wellness programs Food service operations We offer unmatched opportunities for professional... ...as a Clinical Dietitian. You’ll provide Medical Nutrition Therapy and education in an...OperationsMedicalFull timePart timeRelocation packageFlexible hoursCompass Healthcare
Fountain Valley, CA2 days ago- ...UCI Health is the clinical enterprise of the... ...main campus, UCI Medical Center, a 459-bed... ...Medicine and the President and Chief... ...UCI Health, the Vice President, partners... ...management with the operational application of regulations... ...practices, legal/regulatory changes and...MedicalMonday to Friday
University Of California Irvine
Irvine, CA2 days ago $37.27 - $54.01 per hour
Title: Clinical Research Coordinator I Location: Fountain Valley/Laguna... .... Across our family of medical centers, we support each one... ..., company and trial Standard Operating Procedures (SOPs), Good Clinical... ...documentation in the regulatory binder(s) as required by regulations...OperationsMedicalFull timeLocal areaShift work$62 per hour
...Clinical Lab Scientist, Sr PD Location: Fountain Valley Department: Clinical Lab -... ...includes four leading hospitals, award-winning medical groups consisting of over 200 sites of... ...Scientist will oversee the general operation of the laboratory in the absence of the...OperationsMedicalDaily paidShift workAfternoon shift
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