- Merck & Co. (Rahway, NJ)
- …Functional Area: Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate Director ... Management, Employee Training Programs, FDA Regulations, Life Science, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Policy Implementation, Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer 2026. This full-time ... are seeking a detail-oriented and tech-savvy student to join our Global Regulatory Affairs Labeling Operations team as an intern.The Global Regulatory … more
- Eisai, Inc (Nutley, NJ)
- …broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new/innovative drug registration strategy/submissions. ... Transparency Language:The annual base salary range for the Director, Global Regulatory Affairs , Growth Markets is from :$200,800-$263,600Under current… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs , CMC will be responsible for reviewing the CMC post ... approval changes, providing regulatory impact assessments, and coordinating with regional RA -CMC leaders to formulate regulatory strategies for post-approval… more
- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global … more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** **Responsibilities** + Work closely within the Regulatory Affairs function to identify process opportunities & gather ... to enhance Automation and AI skills (including Microsoft Work package) across Regulatory Affairs organization. + Share knowledge and best practices within… more
- Parexel (Trenton, NJ)
- …go-to expert for global labeling, working side-by-side with client teams across Regulatory Affairs , Technical Operations, Safety, and Commercial. You'll help ... This role is ideal for a candidate with a strong background in regulatory affairs , labelling strategy, and cross-functional leadership. It offers the opportunity… more
- Parexel (Trenton, NJ)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... leads in developing contingency plans for CMC-related scenarios - Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory… more
- embecta (Parsippany, NJ)
- …market new or modified devices in both the US and Europe, and related regulatory affairs activities to ensure compliance with regulations and alignment with the ... objectives of the business. This role will also represent regulatory affairs and provide leadership across multiple project development teams by interpreting and… 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 ... Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate Principal Scientist is responsible for?developing and?implementing… more
