- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible... Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …specialty and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to ... with stakeholders and QA line functions. Support the annual Quality Plan for Global Medical Affairs Quality Assurance, PVQA strategic plans and the tracking… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Division of the Company (including, for example, Market Access, Sales, Marketing, Medical Affairs ) as well as DSI employees performing Global roles in the ... limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside...United States (such as Global Marketing, Global Medical Affairs ). For these areas, acts… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and will work regularly with all business areas (Sales, Marketing, Clinical, TMPC, Med Affairs , and Regulatory Affairs ) and support functions (IT, Finance, ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Catalent Pharma Solutions (Somerset, NJ)
- ** Regulatory Affairs Project Manager ** **Position Summary** Catalent Pharma Solutions is hiring a Regulatory Affairs Project Manager **.** The ... Regulatory Affairs Project Manager is responsible for ensuring that the company aligns...Days.** **This is a remote position.** Catalent is a global , high-growth, public company and a leading partner for… more
- dsm-firmenich (Princeton, NJ)
- Regulatory Affairs Manager /Personal Care...of personal care products and being integrated to the global regulatory team. + Contribute to the ... centric mindset? Join us in our journey! As a Regulatory Affairs Manager North America...global PC strategy and as part of a global innovation team. + Responsible for handling regulatory… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of ... regulatory affairs related to the development of...+ Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** The Manager , Regulatory Affairs - Regulatory Project Management ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible... Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …preparation of challenging communications + Manage the preparation for interaction with global regulatory authorities (eg, meetings, IR responses, inspections) + ... RA in a timely manner + Participate in global RA meetings, provide regulatory interpretation, position, and strategies to support CMC/CP prduct development… more
- Henkel (Bridgewater, NJ)
- …a thorough knowledge of products, chemistries and processes. + Leads regional and global product safety and regulatory affairs projects to simplify, ... Madison Heights, MI, United States, Bridgewater, NJ, Adhesive Technologies **Product Safety & Regulatory Affairs Specialist** At Henkel, you can build on a… more
- Abbott (Princeton, NJ)
- …of information + Cross-functional collaboration/interaction with Clinical Affairs , R&D, Regulatory , Quality, OEC, Legal, Global Marketing & Commercial teams ... of strategic initiatives. . Ensures team member adherence to regulatory and compliance guidelines in all aspects of scientific...+ Supporting the Director of Global Scientific Affairs , in conjunction with the Sr. Manager … more
- Ascendis Pharma (Princeton, NJ)
- …and services are fully compliant with Ascendis SOPs and US as well as global regulatory and compliance rules/law. Requirements . MD or MD/PhD or equivalent ... Affairs will report to the US General Manager with primary responsibility to lead the US Medical...Ascendis Pharma. . Works closely with Compliance, Legal and Regulatory to ensure that all US Medical Affairs… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be ... issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk...the Labeling cross functional teams including clinical, safety, medical affairs , and commercial, to ensure highly effective communication of… more
- J&J Family of Companies (Titusville, NJ)
- …FDA Update training, Promotional Review Copy (PRC) Meetings, HealthCare Compliance Teams, Global Regulatory Functional Teams, Product Labeling Teams and Compound ... Manager , Regulatory Advertising & Promotion -...functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs , Regulatory Affairs , Sales, Marketing,… more
- Abbott (Princeton, NJ)
- …Opportunity** Our location in Princeton, NJ currently has an opportunity for a Global Product Manager , Cardiac/Coagulation Assays Portfolio. This role will have ... Abbott is a global healthcare leader that helps people live more...relationship with regions and cross functional teams including Medical Affairs , R&D, Regulatory , Quality, Demand & Supply… more
- Integra LifeSciences (Princeton, NJ)
- …and evaluations + Monitors product development progress with engineering, manufacturing, regulatory affairs and related departments to ensure product line ... outcomes. **SUPERVISION RECEIVED** Under direct supervision of Associate Director, Global Marketing - Surgical Reconstruction, TT **SUPERVISION EXERCISED** None… more
- Integra LifeSciences (Princeton, NJ)
- …a, large company franchise, is preferred. + A deep understanding of global regulatory environments, healthcare trends, clinical trials, and health economics ... including field sales, country marketing teams, product development, finance, regulatory , clinical/medical affairs , business development and others; demonstrates… more
- Bausch Health (Bridgewater, NJ)
- …with cross functional teams including Project Management, Clinical Operations, Clinical/Medical Affairs , Biostatistics and Regulatory Affairs for the ... Bausch Health is a global company that develops, manufactures, and markets a...health care products. JOB DESCRIPTION + The clinical pharmacology manager will support the design, execution, interpretation and reporting… more
- Merck (Trenton, NJ)
- …with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs , Global Medical and Scientific Affairs ... Monitoring Visits Reports and escalates performance issues and training needs to CRA- Manager and/or functional vendor and internal management as needed. + Performs… more
