- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on regulatory ... Under the mentorship of the Sr. RA Manager of Regulatory Affairs , they are responsible for the...requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- ThermoFisher Scientific (Wilmington, NC)
- …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** Join Us as a Director Regulatory Affairs - Make an Impact at the Forefront of ... Innovation The Director Regulatory Affairs provides operational leadership for the...guidelines; advanced knowledge of at least one of the regulatory specialty areas: preclinical, clinical, CMC , publishing,… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Parexel (Des Moines, IA)
- …country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life ... DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely,… more
- Capgemini (New York, NY)
- …& Experience** **Skills & Experience (Required)** + **12+ years** in regulatory affairs ; direct leadership of **IND/NDA/BLA/MAA** submissions (10+ successful ... Capgemini Invent - LS Reg Affairs & Qlty - Sr Consultant At Capgemini...As a Senior Consultant, you'll act as a **trusted regulatory advisor** for pharma and biotech clients, leading engagements… more
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …precision mental health care. 2. Provides consultation to investigators on all regulatory oversite of the research portfolio and in particular clinical trials. ... and family psychotherapy. 5. Provides consultation to professional staff within CMC VAMC system and to community providers, concerning clinical assessment findings… more
- Boehringer Ingelheim (Duluth, GA)
- …vision or to improve collaboration. The stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with ... Operations Excellence Partner is to partner with the USA Regulatory Affairs team in executing key strategic...initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving… more
- Organon & Co. (Plymouth Meeting, PA)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... study protocols are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans. The Clinical… more
- Pfizer (Collegeville, PA)
- …**QUALIFICATIONS / SKILLS** + Bachelor's or Master's degree, preferably in Life Sciences, Regulatory Affairs , Data Management, or related field. + 8+ years of ... data. + Lead open communication pathways with TA aligned Regulatory and CMC Strategy partners, including GRS...experience in Regulatory Affairs or Regulatory Operations,… more
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