- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction ... 5-7 years' experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC ... a site based position located in Foster City, CA_** The Associate Director , Analytical Regulatory Science, collaborates with product development, manufacturing… more
- AbbVie (Pleasanton, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director of Regulatory Affairs - Body Contouring and ... of work and employee accountability, further develop the team to ensure a quality mindset. Provides leadership and expertise for: regulatory operations, change… more
- Stryker (Fremont, CA)
- …external/internal sources and partners with other functions such as Clinical Operations, Medical Affairs , Regulatory Affairs and Marketing to obtain ... link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Global Clinical Evidence and Medical Affairs **… more
- Unilever (San Francisco, CA)
- …THE DETAILS LOCATION: San Francisco or Los Angeles, CA HOURS: Full-time, Exempt MANAGER: Regulatory Affairs Director PLEASE NOTE: Candidates must be ... THE ROLE: REGULATORY AFFAIRS MANAGER You are...OLLY business. This role will partner with Product Development, Quality , Sales, Brand, Marketing, and Creative teams to provide… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with the community of US health care professionals and advocates, ensuring high- quality deliverables such as medical affairs resources, medical presentations at ... headquarters in Foster City, California. **Job Overview:** The Executive Director (ED) USMA Strategy - HIV Treatment is a...US Government Affairs and Policy, US Public Affairs , US Regulatory , and US legal and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. **JOB** **DESCRIPTION** + ... 35 countries worldwide, with headquarters in Foster City, California._ **Senior Director - Analytical Regulatory ** **Science** **KEY** **RESPONSIBILITIES** The… more
- BeiGene (Emeryville, CA)
- …partnerships with key business stakeholders, including Clinical Operations, Clinical Development, Regulatory Affairs , Data Management, Biostats, GPS, RBQM, etc. ... **General Description:** The Associate Director of R&D Quality Systems, Strategy,...regulatory compliance. Help drive implementation of Risk Based Quality Management and Quality by Design principles.… more
- Vera Therapeutics (Brisbane, CA)
- …teams, including product development, manufacturing, clinical development, supply chain, commercial, quality , and regulatory affairs , to ensure ... Title: Associate Director , Quality Assurance - Medical Device/Combination...cross-functional teams to ensure that the combination product meets regulatory standards, are safe and effective for patient use.… more
- Vera Therapeutics (Brisbane, CA)
- …team. The Associate Director , Quality Assurance will report to the SVP, Regulatory Affairs & Quality Assurance and will be responsible for developing ... Title: Associate Director , Quality Assurance Location: Brisbane, CA...regulations and per industry standards. * Assess and assure quality and regulatory compliance related to GCPs,… more
- Abbott (Alameda, CA)
- …various leadership teams across Global Operations, Engineering, R&D, Commercial Operations, Regulatory Affairs , and Legal. + Interfacing with external business ... working mothers, female executives, and scientists. **The Opportunity** The Associate Director supports and coordinates the Quality Assurance activities for… more
- Vera Therapeutics (Brisbane, CA)
- …to medical writing activities for all of Vera's drug development programs, producing high quality regulatory and clinical documents that meet regulatory and ... scientifically accurate manner. * Work with functional representatives such as regulatory affairs , clinical and nonclinical development, clinical pharmacology,… more
- BeiGene (Emeryville, CA)
- …BeiGene SOPs, work instructions, and quality standards * Apply legal, regulatory , and compliance requirements to all Medical Affairs activities **Supervisory ... **Essential Functions of the job:** Under the leadership of the Executive Director , GMA LD&C, collaborate cross-functionally to develop and implement a comprehensive… more
- Abbott (Alameda, CA)
- …* Responsible for aspects of medical and clinical team contributions to regulatory strategy, regulatory filings, quality management system reviews ... female executives, and scientists **_THE OPPORTUNITY_** This Senior Medical and Clinical Director position works out of **Alameda, CA** location. Abbott has a rich… more
- Vera Therapeutics (Brisbane, CA)
- …CMC aspects of clinical products in early-to-late development to create high quality regulatory submissions that support product development strategy. * Author ... team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be... content that meets current regional requirements. * Represent Regulatory Affairs (Clinical and CMC) on cross-functional… more
- BeiGene (Emeryville, CA)
- …+ Clinical Development + Clinical Business Operations + Biometrics + Medical Monitors + Regulatory Affairs + Interacts with all levels of BeiGene + BGNE ... inspection readiness, hosting and coordinating GCP inspections conducted by regulatory health authorities such as FDA, EMA, CFDI, MFDS,...meetings and discussions, as needed + Act as R&D Quality Delegate for the Executive Director , R&D… more
- CSL Plasma (Hayward, CA)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA). **Job Description** + Serves… more
- Gilead Sciences, Inc. (Foster City, CA)
- …will improve the lives of patients with life-threatening illnesses worldwide. As the ** Director of Pricing & Contracting Governance** , you will play a vital role ... evaluated, and approved. You will ensure that all proposals adhere to high- quality standards, format, and structure before cross-functional teams and US Commercial… more
- BeiGene (Emeryville, CA)
- …Collaboration:_ + Work closely with internal teams including Manufacturing Operations, Quality Assurance, Regulatory Affairs , Strategy and Corporate ... **General Description:** The Executive Director for Manufacturing Operations Business Development will be...collaborations, and acquisitions + Stay informed of industry developments, regulatory changes, and new technologies to drive innovation and… more
- Vera Therapeutics (Brisbane, CA)
- … Operations and Publishing will be a key contributor to Vera Therapeutics' Regulatory Operations and Regulatory Affairs teams with accountability for ... Coordinate with external publishing vendors and consultants for on-time delivery of high- quality regulatory submissions. * Conduct final review of published… more