- Novo Nordisk Inc. (Plainsboro, NJ)
- …multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions Serve as a member ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator meetings Serve ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …creating business results with impact on VP/CVP level. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of ... external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key...HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead (s), Global Safety… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …America and LATAM and other relevant stakeholders to ensure compliance with global recruitment process standards and regulatory requirements. Support TA teams' ... (KPIs) and Service Level Agreements (SLAs) Relationship Reports to a Director in the Global Talent Acquisition CoE, responsible for Global TA Strategy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …3 days in office and 2 days remote. Approximately 20-30% overnight travel. Global Job level: Director Development of People Ensure that reporting personnel ... with us? The Position The HCP / KOL Strategy lead will be a pivotal driver in shaping an...market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders… more
- Tris Pharma (Monmouth Junction, NJ)
- …immediate opening in our Monmouth Junction, NJ facility for an Associate Director , Alliance Management.Tris Pharma has a long track record of successful alliances, ... from global commercial partnerships to R&D collaborations to manufacturing/distribution partnerships....across all stages of the product lifecycle. The Associate Director , Alliance Management will be accountable for managing alliances… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent, ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support. Key internal relationships include brand marketing, market… more
- Bristol Myers Squibb (Princeton, NJ)
- …Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead regulatory dossier ... personal lives. Read more: careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products… more
- Merck (North Wales, PA)
- **Job Description** **Principal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director /Senior ... their assigned projects. **Position Description** The Principal Scientist / Director responsibilities include but are not limited to: +...+ Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- J&J Family of Companies (Trenton, NJ)
- Director , Global Regulatory Leader (GRL) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global ... more at www.janssen.com . Key Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead...exist + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Bristol Myers Squibb (Princeton, NJ)
- …teams on practical aspects of global change management. **Responsibilities** Represent regulatory CMC on and/or lead matrix teams for biologics pipeline ... of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with...to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for… more
- Ascendis Pharma (Princeton, NJ)
- …US & Americas labelling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy . ... for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will...for the United States and the Americas and supporting global needs as required. The RA Associate Director… more
- Bristol Myers Squibb (Princeton, NJ)
- …to:** + New Product Portfolio working closely with their TA counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and ... and maintenance of global compliant labels. Position will also serve as Global Labeling Lead for assigned products. **Responsibilities include, but are not… more
- J&J Family of Companies (Trenton, NJ)
- Director , Regulatory Medical Writing (1 of 4) - 2406211847W **Description** Johnson & Johnson is currently seeking a Director , Regulatory Medical ... potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a...plan, assessment aid) documents is preferred. + Knowledge of global regulations, regulatory timelines, guidelines, and … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and… more
- Taiho Oncology (Princeton, NJ)
- …Summary: Under the leadership of Regulatory Affairs the incumbent manages global regulatory operational activities (except Asia) for all Taiho Oncology, ... Associate Director , Regulatory Affairs Operations Pleasanton, CA,...contract review and negotiation. + Strong working knowledge of global regulatory requirements and submission processes. +… more
