- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director / Principal Scientist, Regulatory Affairs Liaison , is responsible for the development and implementation of worldwide regulatory strategy ... and provide regulatory oversight for assigned products in order to optimize product labeling and obtain shortest time to approval by regulatory agencies.You will… more
- Eisai, Inc (Nutley, NJ)
- … Director will direct the development and submission of investigational drug applications, product registration dossiers, supplements, amendments, as ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for...well as providing strategic product direction to project teams on interacting and negotiating… more
- J&J Family of Companies (Raritan, NJ)
- …at** **https://www.jnj.com/innovative-medicine** **We are searching for the best talent for a Director , Investigational Product Preparation and Strategy ... to ensure consistent program deliverables including the development/authoring of the investigational product preparation and administration instructions… more
- J&J Family of Companies (Raritan, NJ)
- …**https://www.jnj.com/innovative-medicine** **We are searching for the best talent for an Associate Director , Investigational Product Preparation and ... Strategy.** Beerse, Belgium - Requisition Number: R-016743 Associate Director , Investigational Product Preparation and Strategy **.** This is a remote… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …regulatory submissions, which require cross-functional interactions for commercial or investigational product (s). Examples include meeting requests, briefing ... of where they live or their economic status. **POSITION OVERVIEW:** As a Director , Early Oncology Global Regulatory Affairs, you will develop and execute Oncology… more
- J&J Family of Companies (Raritan, NJ)
- …and Market Access). This role will also provide strong input on long-term product opportunities and portfolio strategies. The Medical Director will work closely ... competitive analysis, new product development, clinical research, new business development, product training during investigational trials as well as during … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …regulatory submissions, which require cross-functional interactions for commercial or investigational product (s). Examples include meeting requests, briefing ... a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …regulatory submissions, which require cross-functional interactions for commercial or investigational product (s). Examples include meeting requests, briefing ... a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for… more
- Merck (Rahway, NJ)
- **Job Description** The Director /Principal Scientist, Regulatory Affairs Liaison, is responsible for the development and implementation of worldwide regulatory ... and provide regulatory oversight for assigned products in order to optimize product labeling and obtain shortest time to approval by regulatory agencies. You… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …documentation and processes, including core data sheets, prescribing information, and target product labels for both marketed and investigational products. + ... teams. Regulatory Affairs Global Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead...You will lead one or more teams in the preparation and submissions of USPIs as part of BLAs,… more
- Rockefeller University (New York, NY)
- …with significant activities involving both investigational drug products and sterile product preparation ; + NYS Pharmacist license in good standing; + ... on needed actions, maintain required aseptic procedures, maintain the sterile product preparation area, maintain refrigerator/freezer temperature records, and… more
