- BD (Becton, Dickinson and Company) (San Diego, CA)
- …learn, grow and become your best self. Become a **maker of possible** with us. The Sr. Director , Regulatory Affairs is the ranking Regulatory Affairs ... Regulatory Affairs + Represents the Platform in interactions/negotiations with global regulatory agencies and Notified Bodies; enables / empowers staff to… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Position Summary** : Reporting to the Vice President, Global Medical Affairs , the Executive Director , CNS Strategy, Global Medical Affairs is a ... but are not limited to the following: + Represents Global Medical Affairs on extended brand leadership...Otsuka prominence in CNS space + Provides input into regulatory documents, including product labeling + Accountable for resourcing… more
- GRAIL (Menlo Park, CA)
- …with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Preferred… more
- Oura (San Francisco, CA)
- …do their best work - both in and out of the office. We are looking for a Director , Regulatory Affairs and Quality Assurance to play a key role in shaping ... Ensure compliance with FDA, CE (MDR), and other relevant global regulatory frameworks. + Review marketing and...you have: + Bachelor's degree in life sciences, engineering, regulatory affairs , or a related field; advanced… more
- Kelly Services (Anaheim, CA)
- ** Director of Quality and Regulatory Affairs ** Kelly(R) Science & Clinical is seeking a ** Director of Quality and Regulatory Affairs ** for a ... , and dietary supplement industry, with strategic knowledge of USA and global regulations. + Proven experience interfacing with regulatory bodies such… more
- Gilead Sciences, Inc. (Foster City, CA)
- …degree with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of ... together. **Job Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and leads global ... Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs (CMC RA) or other relevant...(IND, IMPD/CTA, NDA, MAA, etc.). + Deep understanding of global regulatory requirements and guidelines. + Ability… more
- Stryker (San Jose, CA)
- The **Senior Director , Regulatory Affairs ** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** and ... with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Senior Director and team will develop and advise on product positioning, product entry… more
- BeOne Medicines (Emeryville, CA)
- …Senior Director , Investigator-Initiated Trials (IIT) and Expanded Access Programs in Global Medical Affairs . The ideal candidate will be responsible for ... non-medical functions (eg, Marketing, Market Access, HEOR, Legal, Compliance, Regulatory , etc.). This position will also assist with program...IIT, EAP and Phase IV BeOne-sponsor study programs within Global Medical Affairs . + Functions as a… more
- BeOne Medicines (Emeryville, CA)
- The Global Executive Medical Science Director (ex-China) for Hematology GMA will report directly to the Vice President, Hematology Lead for GMA. Under the ... VP, She/he will be responsible for developing and implementing all aspects of the global medical strategy for BeOne Hematology assets. The primary focus will be to… more