- Novo Nordisk (Plainsboro, NJ)
- …ready to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical ... professional having a wide range of experience and a complete understanding of Regulatory Labeling roles and responsibilities + Demonstrates full knowledge of… more
- Integra LifeSciences (Princeton, NJ)
- … regulatory compliance, and cost management/process efficiency objectives. The Labeling Associate will collaborate with cross-functional teams, including ... patient outcomes and set new standards of care. The Labeling Associate will assist with the execution...ensuring compliance with both internal corporate standards and external regulatory requirements. This role will be assisting the strategic… more
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Labeling Associate - Design is responsible for creating, reviewing, approving, and ... members for and project teams on all project execution + Assist the Senior Labeling Associate in integrating and implementing Integra's electronic labeling … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides ... strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of… more
- Colgate-Palmolive (Piscataway, NJ)
- …goals. Together, let's build a brighter, healthier future for all. **Scope:** The Regulatory Affairs Associate Manager supports Colgate's Oral Care and Personal ... Care divisions. This position involves engaging in regulatory activities necessary for the maintenance of existing products as well as the development and… more
- Novo Nordisk (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...potential data/claims with manager oversight + Participate/assist in US labeling negotiations as necessary. Ensure that changes in US… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... pharmaceutical products across therapeutic areas + Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global… more
- IQVIA (Bridgewater, NJ)
- …particular. Experience in developing evidence dossiers and briefing books to support product labeling based on PRO and other COA endpoints consistent with the Food ... processes for COA Consulting services; training and mentoring Associates, Associate Consultants, Consultants, and Managers in these Project Management processes… more
- Bristol Myers Squibb (Princeton, NJ)
- …FDA guidelines. The role works closely with the Proofreading team, Labeling Operations, Commercial Regulatory Affairs, and Worldwide Commercialization Excellence ... responsible for the seamless implementation of prescribing information and all derivative labeling documents across all brands. This is an important role within US… more
- Bristol Myers Squibb (Princeton, NJ)
- …Channel Operations is responsible for managing the operational processes associated with product labeling updates in the US market. This role will define, drive, and ... brands. The role works closely with the Brand Teams, Commercial Regulatory Affairs, Worldwide Commercialization Excellence (WCE) and the cross-functional teams on… more
- Hackensack Meridian Health (Edison, NJ)
- …compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries ... as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within… more
- Integra LifeSciences (Plainsboro, NJ)
- …in ensuring that products meet the required safety, performance, and regulatory standards before they reach the market. Their responsibilities typically include: ... visual, mechanical, and sometimes functional tests to ensure products meet regulatory requirements (such as FDA or ISO standards). Documentation and Reporting:… more