- Bausch Health (Bridgewater, NJ)
- …it-where 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on...you if:** + If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. Job Scope: 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
- 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 ... 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)
- …regardless of where they live or their economic status. **POSITION OVERVIEW:** As a Director , Early Oncology Global Regulatory Affairs , you will develop and ... or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help...conditions of the applicable plans. **For jobs in the United States :** Gilead Sciences Inc. is committed… 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...conditions of the applicable plans. **For jobs in the United States :** Gilead Sciences Inc. is committed… more
- Merck (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... **Job Description** Reporting to the Executive Director , RIIM, this role will be accountable to...Regulatory Submissions, Management Process, People Leadership, Product Lifecycle, Regulatory Affairs Compliance, Regulatory … more
- Bausch Health (Bridgewater, NJ)
- …CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry ... 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people...drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for… 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 ... US FDA/EU EMA interactions with support from higher-level manager. + ** Regulatory Knowledge:** Demonstrates expert knowledge of US /EU regulatory … more
- Bristol Myers Squibb (Madison, NJ)
- …BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that... . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… 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)
- …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... reports to external agencies. + Works on other regulatory projects and duties as assigned. **About Us… more
- Merck (Rahway, NJ)
- **Job Description** The Director /Principal Scientist, Regulatory Affairs Liaison, is responsible for the development and implementation of worldwide ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and...in certain states and cities within the United States . Final determinations with respect to… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care...compliance with Sanofi's behavioral and ethical standards **Why Choose Us ?** + Bring the miracles of science to life… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** **Position Summary:** The Director of US Medical Affairs Agile Innovation is a ... leader responsible for agile acceleration of innovation across the US Medical Affairs function by deploying transformative...conditions of the applicable plans. **For jobs in the United States :** Gilead Sciences Inc. is committed… more
- J&J Family of Companies (Raritan, NJ)
- …MD **Job Category:** People Leader **All Job Posting Locations:** Raritan, New Jersey, United States of America **Job Description:** Johnson and Johnson is ... currently seeking a **Medical Director , Global Medical Affairs , Biosurgery located** in...partners including but not limited to R&D, Clinical Research, Regulatory Affairs , Communications, Legal, Quality & Compliance,… more
- Bayer (Whippany, NJ)
- … Us ** **Email:** hrop_###@bayer.com **Job Segment:** Marketing Communications, Regulatory Affairs , Compliance, Clinical Research, Medical Research, Marketing, ... executives in Marketing, Sales, Manufacturing, Drug Safety, Quality Assurance, Regulatory Affairs and Legal Departments; + The...contact information below. Bayer is an E-Verify Employer. **Location:** United States : New Jersey : Whippany… more
- AbbVie (Florham Park, NJ)
- …our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn ... *Position title will be based on qualifications listed below. Purpose: The Director provides specialist medical and scientific strategic and operational input into… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Director , Clinical Development and Medical Affairs (Respiratory) Requisition JR000014860 Director , Clinical Development and Medical Affairs ... Location Bridgewater, NJ Additional Locations Job Description Summary Job Description The Director of Clinical Development and Medical Affairs ( Respiratory)… more