- Chiesi (Cary, NC)
- …+ Promotional Material/External Communications Responsibilities: + Heads Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, ... + Prepare Standard Operating Procedures for related activities and provide training to Regulatory Affairs and other departments as appropriate. + Review and… more
- Danaher Corporation (Boston, MA)
- …Business Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will...in the Biopharma sector. This position reports to the Director , Regulatory Affairs and is… more
- United Therapeutics (Jefferson City, MO)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of...Ability to mentor, coach, guide, and train lower to senior level employees **Preferred Qualifications** + Proficient knowledge of… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... thought was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… more
- Fresenius Medical Center (Waltham, MA)
- …(Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years ... portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...of experience in regulatory affairs , focusing on regulatory … more
- BeOne Medicines (Cambridge, MA)
- BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Director , Regulatory Affairs in Cambridge, MA, USA: **Job Duties:** + Provides high level regulatory ... direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the submission preparation process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development. + Exercises expertise in the ... degree with directly relevant professional experience in biologics product development, global CMC regulatory affairs , and CMC technical areas of at least 14… more
- Gilead Sciences, Inc. (Foster City, CA)
- …guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and leads global ... draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior...Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs (CMC RA) or other relevant… more
- Takeda Pharmaceuticals (Boston, MA)
- …probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
- BeOne Medicines (San Mateo, CA)
- …We currently have an exciting opportunity available for an experienced Senior Director , Investigator-Initiated Trials (IIT) and Expanded Access Programs ... in Global Medical Affairs . The ideal candidate will be responsible for effective...non-medical functions (eg, Marketing, Market Access, HEOR, Legal, Compliance, Regulatory , etc.). This position will also assist with program… more
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