- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …Preferred **Knowledge and skills** + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry ... Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and… more
- Parexel (Trenton, NJ)
- …* Deep understanding of regulatory requirements for drug development, global labeling , and post-marketing. * Strong problem-solving skills with the ... across multiple therapeutic areas. * Gain exposure to advanced regulatory systems and global labeling strategies. * Competitive compensation, benefits, and… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... Innovative Medicine R&D is recruiting for a Senior Manager, Global Labeling Product Leader. This position is...develop methods for planning, directing, coordinating and controlling the regulatory affairs activities related to new and… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling , medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Sumitomo Pharma (Trenton, NJ)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international...to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an… more
- Kelly Services (Bridgewater, NJ)
- ** Regulatory Affairs Specialist Labeling ** Kelly(R) Science & Clinical is seeking a Regulatory Affairs Specialist - Labeling for our client based ... approvals + Knowledge of pharmaceutical, consumer or medical device industry regulatory affairs discipline throughout the product lifecycle including… more
- Bristol Myers Squibb (Princeton, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director Commercial Regulatory Affairs ** **Description** : The role of Associate ... Director of US Commercial Regulatory Affairs requires the ability to apply...and subpart E and H submissions + Ensure full regulatory compliance of all promotions with approved labeling… more
- Oracle (Trenton, NJ)
- …across global markets that impact to our businesses, regulatory affairs function, and quality/compliance programs. **Responsibilities** **Preferred ... To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing… more
- GRAIL (Trenton, NJ)
- …with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- Sumitomo Pharma (Trenton, NJ)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will ... primarily function as a regional regulatory leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Actalent (Branchburg, NJ)
- …on SDS and labeling requirements to internal stakeholders. Essential Skills + Regulatory affairs + Labeling + Quality assurance + Document control ... Label Specialist is responsible for ensuring compliance with global regulatory requirements related to chemical safety...& Qualifications + Bachelor's degree in Chemistry, Environmental Science, Regulatory Affairs , or related field. + 3+… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Global Program Leads within the ICV Global Program Leadership ... late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision… more
- J&J Family of Companies (Raritan, NJ)
- …R&D and GCSO functions, including the Clinical Development Team (CDT), Commercial, Medical Affairs , and Global Market Access COE to ensure optimal launch ... America, Raritan, New Jersey, United States of America **Job Description:** **Director, Global Compound Market Access Leader, GU Oncology Early Pipeline & NBD**… more
- Ascendis Pharma (Princeton, NJ)
- …promotional assets for assigned product(s), and collaborate with Commercial, Legal, and Regulatory for development and review of Labeling , advertising, and ... Regulatory , Clinical Development, Clinical Operations, Compliance, Pharmacovigilance, Biometrics, Global Communications, and other functional group contributors to support… more
- Novo Nordisk (Plainsboro, NJ)
- …on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Global HQ. Key internal relationships include Field Medical Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical… more
- J&J Family of Companies (Titusville, NJ)
- …via matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality ... clinical study reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …Department, Marketing, Sales, Research and Development, strategy/portfolio management, Regulatory Affairs , and Pharmacovigilance. External collaboration includes ... The Senior Medical Director, Rheumatology, will serve as a critical member of the Global Medical Affairs team. They are responsible for leading and driving the… more
- Ascendis Pharma (Princeton, NJ)
- … labeling , investigator brochures, protocols, informed consent forms, and regulatory submissions + Collaborate with internal and external stakeholders on ... patient safety and ready to help lead a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking an experienced...pharmacovigilance agreements, audits, and regulatory inspections + Monitor industry… more