- Haleon (Warren, NJ)
- …and + identifying emerging regulatory trends and evolving FDA expectations. **The Regulatory Affairs Co -Op Associate** The objective of the Regulatory ... providing visibility to potential gaps. In this role, the Co -Op Associate will be provided with the opportunity...wide format used for submissions to the FDA. The Regulatory Affairs Co -Op will be… more
- Sumitomo Pharma (Trenton, NJ)
- … Regulatory Affairs , Biopharma R&D. This position leads the Regulatory Affairs for biopharma R&D, report to the Chief Development Officer for ... Duties and Responsibilities** **_Regulatory Strategy_** + Develop and Manage Regulatory Affairs Strategy + Develop and gain... Regulatory matters in close partnership with the Chief Development Officer and other key stakeholders… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs ** . The Director is part of the Global ... Sumitomo Pharma Co ., Ltd. is a global pharmaceutical company based...Regulatory Affairs (GRA) team based in the...prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission +… more
- Organon & Co. (Jersey City, NJ)
- …Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and outside. + Communicate new legislations, guidelines and ... entire life cycle of the drug. + Represent Global Regulatory Affairs within our company's internal committees...For more information about personal rights under Equal Employment Opportunity , visit: EEOC Poster EEOC GINA Supplement OFCCP EEO… more
- Haleon (Warren, NJ)
- … to be part of something special. **About the role** This **Senior Manager, Regulatory Affairs - OTC** has responsibility for end-to-end regulatory ... we're in control of. In an environment that we're co -creating. And a culture that's uniquely ours. Care to...similar discipline + Minimum 8 years of experience in regulatory affairs + Experience working on FDA… more
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small… more
- Merck (Trenton, NJ)
- …+ Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. + Provide ... brochures + Local registration study protocols for secondary markets + Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD)… more
- J&J Family of Companies (Raritan, NJ)
- …closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as Project Management, Medical Writing, Clinical and ... of a Bachelor's degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs or a related discipline. Advanced degree preferred. + A… more
- Sanofi Group (Morristown, NJ)
- …actively contribute to issue resolution before filing dates are impacted + Act as Regulatory Operations Team expert providing subject matter advice on ICH, eCTD, ... and Policies throughout the lifecycle of the application. + Coordinate with Regulatory Operations external equivalent to develop milestones and timelines and… more
- Sumitomo Pharma (Trenton, NJ)
- … Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... Sumitomo Pharma Co ., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo… more