- J&J Family of Companies (Raritan, NJ)
- …Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a ** Senior RA Professional , Submissions , CAPAs** . This ... **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** Professional … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Haleon (Warren, NJ)
- …It's an opportunity to be part of something special. **About the role** This ** Senior Manager, Regulatory Affairs - OTC** has responsibility for end-to-end ... regulatory strategy to deliver timely approvals for US submissions and OTC Monograph product launches. + Develop and...similar discipline + Minimum 8 years of experience in regulatory affairs + Experience working on FDA… 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 ... Regulatory Affairs (GRA) team based in the...applicable documents/ activities. + Plans, coordinates, authors, and prepares regulatory submissions and works closely with … more
- Nestle (Bridgewater, NJ)
- …support for proactive global monitoring and surveillance of changes in the regulatory landscape focused on regulatory submissions requirements, potential ... Operations experience and understanding of the pharmaceutical drug development and global Regulatory submissions requirements in all regions (US, EU, Canada,… more
- Merck (Rahway, NJ)
- …innovation and leveraging it for how we operationalize CMC. This individual will be a senior member of the Regulatory Affairs CMC organization and will also ... lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high-quality submissions ...significant cross-modality projects as an extension of the overall Regulatory Affairs CMC Leadership Team. This 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …collection, storage conditions, and analytical testing, to support product development and regulatory submissions . + Author and review INDs, NDAs, and other ... regulatory submissions , ensuring accuracy, completeness, and adherence...cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments… more
- American Express (New York, NY)
- …practices + Contribute to lessons-learned exercises and process improvements for regulatory submissions and audit responses **Minimum Qualifications** + 4 ... years of experience in risk management, compliance, internal audit, or regulatory affairs , preferably within financial services + Bachelor's degree in risk… more