- Parexel (Trenton, NJ)
- …Consultant level role, 7+ years for a Senior Consultant - Proven success in preparing regulatory documentation for FDA , EMA, and Health Canada (IND, NDA, DMF) - ... experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory ...Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure… more
- Eisai, Inc (Nutley, NJ)
- …requirements worldwide and stay current with labeling guidelines and regulations by FDA , EMA and other applicable regulatory authorities. Represent the Global ... for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage labeling operations and… more
- Genmab (NJ)
- …Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements Demonstrated ... study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …external inspections, and corporate audits. Responsible for follow-up on operational findings from FDA and other regulatory bodies. + Participate in and conduct ... (GDP), and ALCOA++ principles. The role also provides support during regulatory , corporate, and internal audits. **Key Responsibilities** + Support batch… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Nordisk products and in compliance with Novo Nordisk and FDA requirements Responsible for Product Safety compliance across all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...after hours inquiries from healthcare professionals Ensures compliance with FDA requirements as they affect Medical Communications; responses must… more
- Insmed Incorporated (NJ)
- …including INDs, NDAs/MAAs, and other required documentation. Ensuring compliance with ICH, FDA , EMA, PMDA and other international regulatory guidelines will be ... a strategic leader, ensuring that development programs meet scientific, quality, regulatory , and commercial standards, while ensuring execution across internal teams… more
- Merck & Co. (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Lead the Device… more
- Parexel (Trenton, NJ)
- …and evaluating clinical sections of regulatory applications. + Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master ... drug development-we help shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront of innovation, guiding… more
