- Sumitomo Pharma (Sacramento, CA)
- …agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions . Guides and trains project teams on new requirements, ... a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the Senior Manager … more
- Abbott (Alameda, CA)
- …recognized as an expert and resource within the department, leading successful regulatory submissions and interactions with regulatory agencies while ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager ** will work on-site in...related discipline + Previous experience with Class III IDE submissions and/or PMA submissions or EU Technical… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
- Abbott (Alameda, CA)
- …as industry trends and trains staff regarding changing regulations that affect regulatory submissions . Maintains knowledge of current and pending regulations ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations**...of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …the scope of experimentation and the selection of data needed to support regulatory submissions . + Interacts with regulatory authorities regarding programs ... and development of contingency plans. + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements… more
- Abbott (Alameda, CA)
- …cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions , and ensuring data is effectively presented for the ... female executives, and scientists. **The Opportunity** This S **enior Regulatory Affairs Manager - APAC** position will...representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the APAC… more
- Abbott (Pleasanton, CA)
- …and apply regulatory requirements. Compile, prepare, review and submit regulatory submissions to authorities. + Domestic and international regulatory ... executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart...with EU and other international medical device regulations and submissions . + Ability to work in a highly matrixed… more
- Abbott (Alameda, CA)
- …cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions , and ensuring data is effectively presented for the ... for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at… more
- Gilead Sciences, Inc. (Foster City, CA)
- …or other biologic products. + Experience leading development and execution of regulatory submissions of promotional materials for prescription drug or biologic ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within… more
- Kelly Services (Valencia, CA)
- … regulatory programs across two facilities. **Key Responsibilities:** + Oversee regulatory submissions (FDA, EU MDR, international). + Maintain product ... + ** Regulatory Affairs Manager ** + **Location:** Onsite...Proven experience with 5 years or more of FDA submissions and international regulatory compliance. + Lead… more
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