- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Director of Regulatory Affairs coordinates and oversees regulatory ... industry and regulatory experience + Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle + Knowledge of… more
- Bayer (Whippany, NJ)
- …of brilliant and diverse minds to make a real difference, there's only one choice.** ** Director US Regulatory Affairs Liaison** The Director US ... **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Director US Regulatory Affairs Liaison, are to: + Demonstrates, credibly… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Global Labeling is a core function within Gilead's ... Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Global Labeling… more
- Bausch Health (Bridgewater, NJ)
- …CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry ... values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy, to deliver high… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory ... strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and… more
- System One (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (50% hybrid) Type: 12-month contract Must haves: + Must be local for hybrid ... IND/NDA development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in developing and executing regulatory… more
- Novo Nordisk (Plainsboro, NJ)
- …to regulatory agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport ... Position Manage and oversee all assigned projects/products/processes. Assist the Director in assuring Novo Nordisk compliance with internal SOPs...and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary:** Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products. **Responsibilities:** _CDx development_ _:_ Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Mount Sinai Health System (New York, NY)
- …The Flex Staff Hourly employee is a variable one, ranging from entry level clerical support to professional (non-licensed), engaged by a department on an as-needed ... basis, compensated on an hourly basis. Flex Staff employees also include those who retired or terminated from a full-time position, brought back to perform their role on a part-time, temporary basis, often to support or orient the replacement employee.… more
- Mount Sinai Health System (New York, NY)
- …Senior Director , Regulatory Compliance- Mount Sinai Health System** The Senior Director for Regulatory Affairs is responsible for assisting the Vice ... President, Quality and Regulatory Affairs , MSHS, in maintaining a state of regulatory compliance across the MSHS, through proactive tracking, communication,… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination Products will… more
- AbbVie (Florham Park, NJ)
- …*Position title will be based on qualifications listed below. Purpose: The Director provides specialist medical and scientific strategic and operational input into ... core medical affairs activities such as: health-care professional and provider interactions;...content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. + Has overall responsibility for… more
- AbbVie (Florham Park, NJ)
- …title will be based on qualifications listed below. Purpose: The Senior Director provides specialist medical and scientific strategic and operational input into core ... medical affairs activities such as: healthcare professional/provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and… more
- J&J Family of Companies (Raritan, NJ)
- …with business partners including but not limited to R&D, Clinical Research, Regulatory Affairs , Communications, Legal, Quality & Compliance, Preclinical, Health ... America **Job Description:** Johnson and Johnson is currently seeking a **Medical Director , Global Medical Affairs , Biosurgery located** in **Raritan, NJ**… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Marketing/ commercial + GMP QA/ Supply chain / Regulatory Affairs **Leadership/** **team** **management:** + ... areas centered around rare diseases and immune disorders. **JOB SUMMARY** The Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is… more
- City of New York (New York, NY)
- …service--often serve as a model for other cities. The Division of Policy and Community Affairs is seeking a Deputy Director for Community Affairs with strong ... a day, making TLC the most active for-hire transportation regulatory agency in the world with oversight of a... and reporting to the Assistant Commissioner for Community Affairs , the Deputy Director will serve as… more