- Grifols Shared Services North America, Inc (New Brunswick, NJ)
- …Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral ... Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …ICH guidelines; + cGMP standards; + Federal and State laws related to pharmaceutical regulatory affairs; + Business, scientific and personal computer software ... test methods, etc. + Implement policies to assure on-going compliance of Regulatory Affairs activities. + Assess...Pharmaceutics or a related field and 3 years of regulatory experience with a pharmaceutical company. Must… more
- Sanofi Group (Morristown, NJ)
- …as appropriate. **About you** **Experience** : + 1+ year of experience in Regulatory Affairs in the Pharmaceutical industries. + Experience in Global ... ** Regulatory Strategist - VIE Contract** + _Location: United...Authorities questions, labeling changes, risk minimization measures). + Maintain compliance with all internal and external requirements and procedures… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical ... Regulatory filings and provide regulatory leadership on...in close collaboration with leads from other areas. Assure compliance with regulations and with project team timelines. +… more
- Nestle (Bridgewater, NJ)
- …the potential to affect the current portfolio and future pipelines. **Key Responsibilities:** ** Regulatory Compliance ** : * Ensure full regulatory ... and/or dietary supplements regulatory environment with full expertise on regulatory compliance (ie product composition; DSHEA; ingredient qualification, eg,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...approval for either the US or EU. + Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- J&J Family of Companies (Raritan, NJ)
- …licensing, or divestiture of assets, products or businesses. This role ensures regulatory compliance and alignment with applicable global health authority ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
- Kerry (Clark, NJ)
- …of new flavor technologies. The ideal candidate will serve as a strategic regulatory partner, ensuring compliance while strengthening and protecting Kerry Tastes ... taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to...the role As part of Kerrys North America Taste Regulatory Scientific Affairs team, this role will provide … more
- Sanofi Group (Morristown, NJ)
- …compliance activities for assigned deliverables, develops, executes + regulatory submission planning activities, including generating submission content plans, ... **Job Title:** Regulatory Strategist - mRNA Vaccines **Location** : Swiftwater,...enable successful product development and market access, while ensuring compliance with evolving global regulations specific to mRNA technologies.… more
- Bristol Myers Squibb (Madison, NJ)
- …. **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas + Responsible for understanding the regulatory… more