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Regulatory Affairs Specialist
3 weeks ago
Synergy Solutions Hercules, United StatesEssential Onsite · - no hybrid. M-F 8:00 to 4:30 however we are flexible. · *Less than 1 year experience in IVD medical device industry is acceptable* · - Provide regulatory support for IVD products with multiple product groups within clinical diagnostics. · - Work with regulator ...
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Regulatory Affairs Specialist
3 weeks ago
Partnership HealthPlan of California Fairfield, United StatesOverview: · Under supervision and direction of the Regulatory Affairs Manager, this position assists in supporting the plan-wide HIPAA program and Fraud, Waste, and Abuse (FWA) program and acts as a liaison between the plan and our regulatory agencies. This position coordinates ...
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Regulatory Affairs
2 weeks ago
Entegee Hercules, United StatesJob Description · Job DescriptionSummary: Seeking a Regulatory Affairs Specialist with 2-5 years of experience in the IVD industry, to provide regulatory support for product transitions from IVDD to IVDR, ensuring compliance and assisting in documentation and labeling updates. Th ...
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Partnership HealthPlan of California Fairfield, United StatesOverview: · To support the objectives of the regulatory and compliance program and to ensure related activities are in alignment with regulatory requirements, contractual obligations, and ethical standards. · Responsibilities: Maintains awareness and demonstrates understanding ...
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Partnership HealthPlan of California Fairfield, United StatesOverview · To support the objectives of the regulatory and compliance program and to ensure related activities are in alignment with regulatory requirements, contractual obligations, and ethical standards. · Responsibilities · Maintains awareness and demonstrates understanding ...
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Regulatory Affairs Manager
6 days ago
Alameda Health System Walnut Creek, United StatesSummary · SUMMARY: · Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Jo ...
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Regulatory Affairs Manager
1 week ago
Alameda Health System Novato, United StatesSummary · SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Join ...
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Quantum Ventures Alamo, United StatesAllergopharma GmbH & Co. KG, located in Reinbek, is part of the Dermapharm AG corporate group and is an internationally operating pharmaceutical company specializing in the development, production, and distribution of products for the diagnosis and treatment of allergic diseases. ...
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Vice President, Regulatory Affairs, CMC
3 weeks ago
Ultragenyx Pharmaceutical Novato, United StatesBrisbane, CA; Novato, CA; Somerville, MA; or Woburn, MA · Why Join Us? · Be a hero for our rare disease patients · At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do.To achieve ...
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Polaris Pharmaceuticals Inc. Vacaville, United StatesRole Title: Senior Manager/Associate Director, Regulatory Affairs CMC · Department: Regulatory Affairs · FLSA Exempt · CORE VALUES · Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration · ROLE SUMMARY · In this role you will provide CMC strategy input, ...
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Polaris Group Vacaville, United StatesRole Title: Senior Manager/Associate Director, Regulatory Affairs CMC · Department: Regulatory Affairs · FLSA Exempt · CORE VALUES · Respect ? Passion ? Teamwork ? Integrity ? Honesty ? Commitment ? Collaboration · ROLE SUMMARY · In this role you will provide CMC strategy ...
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Manager, Gxp Compliance
2 weeks ago
BioMarin Novato, United StatesWho We Are · BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cuttin ...
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Regulatory Reporting Analyst
3 weeks ago
Partnership HealthPlan of California Fairfield, United StatesOverview: · To develop and implement long-term quantitative analysis strategies to meet NCQA and DHCS · standards for reporting. To perform, and assist in the performance of, duties that ensure the · accuracy, completeness and truthfulness of enterprise wide regulatory reporti ...
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Regulatory Windchill Coordinator
4 weeks ago
The Fountain Group Fairfield, United StatesPay: $35-40/hr · Location: Sylmar, CA - first 2-3 weeks of training must be onsite and then may WFH the rest of the time with One Day In the Office. · Duration: 6 months; possible temp to perm for candidates willing to come onsite · Prefers candidates that are local to Sylmar ...
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Center Medical Director
2 weeks ago
CSL Plasma Fairfield, United StatesJob Description Summary · Provides medical oversight to Medical Staff Associates, including the training of other physicians and Medical Staff Associates. Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (F ...
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Manager, Title Ix/civil Rights Compliance
1 week ago
Napa Valley College Napa, United States**DESCRIPTION**: · **OPEN UNTIL FILLED with an initial review on the week of June 10, 2024.** · Napa Valley College is seeking an individual with demonstrated administrative skills to join an outstanding team of faculty, staff, and administrators to provide high quality programs ...
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Medical Staff Coordinator
2 days ago
County of Contra Costa, California Martinez, United States**The Position**: · **The Board of Supervisors have authorized the following future salary increases**: · **5% on July 1, 2024** · **5% on July 1, 2025** · **Why Join Contra Costa County Health Services?** · The Contra Costa County Health Services Department is offering an excell ...
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Dir Governmental
1 week ago
Calpine Walnut Creek, United StatesCalpine Corporation is America's largest generator of electricity from natural gas and geothermal resources with operations in competitive power markets. Its fleet of 76 power plants in operation and one under construction represents nearly 26,000 megawatts of generation capacity ...
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Associate Director, Regulatory Operations
1 week ago
UPSIDE Foods Berkeley, United StatesJob Description · Job DescriptionAbout us Based in Berkeley, CA, UPSIDE Foods grows meat, poultry, and seafood directly from real animal cells. These products are not vegan or vegetarian—they are delicious meat, made without the need to raise and slaughter billions of animals. In ...
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Reg Affairs Specialist
1 week ago
Entegee Hercules, United StatesJob Description · Job DescriptionSummary: Seeking a Regulatory Affairs Specialist with 0-2 years of experience in IVD regulatory affairs to provide regulatory support for IVD products within clinical diagnostics. · Job Requirements: · 0-2 years of experience in IVD regulatory aff ...
Vice President/Senior Vice President, Regulatory Affairs - Fairfield, United States - Meet Recruitment
Description
Vice President/Senior Vice President, Regulatory AffairsThis range is provided by Meet. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Vice President or Senior Vice President, Regulatory Affairs & Quality Assurance
Meet has engaged on a search for a confidential search for a VP/SVP of Regulatory and Quality with one of our biotech clients.
Our client is focused in the Heme/Onc space - you'll be reporting into C-Suite and will be heading up Reg and Quality for the organization.
Additional details can be provided via phone call.Key Responsibilities
Lead Regulatory Affairs and Quality Assurance functions
Manage all aspects of Regulatory submissions (IND/CTA, NDA/BLA/MAA)
Manage FDA (and ex-US Health Authority) interactions
Key Qualifications
20+ years of industry experience, minimum 10 years of management/leadership experience
Oncology experience required
Full development cycle experience required (pre-IND through commercial)
Startup experience highly preferred
Please reach out to Ryan Moran to setup a confidential conversation:
:
Seniority level
Seniority level
Executive
Employment type
Employment type
Full-time
Job function
Job function
Strategy/Planning, Writing/Editing, and Science
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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