- Bayer (Whippany, NJ)
- …and diverse minds to make a real difference, there's only one choice.** **Assistant Director Regulatory Affairs North America Operations** The Assistant ... Director Regulatory Affairs North America Operations reports directly...to verify identity and eligibility to work in the United States and to complete the required… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... unmet medical needs in North American markets. In the United States , MTPA launched rare disease treatments...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for ... or Microbiology + Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience: 10+ years… 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
- New York State Energy Research and Development Aut (New York, NY)
- …passion to work in a fast-paced environment on the cutting edge of energy policy. The Director , Legal and Regulatory Affairs will report directly to the NY ... Bank's Managing Director , Head of Legal and Regulatory Affairs and be charged with anticipating...or university and admitted to practice law in a US jurisdiction for at least eight years. If bar… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people...promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. +… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... objectives. This group also represents Gilead's commercial activities to US regulatory agencies. You will manage the...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… 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
- Merck (Rahway, NJ)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of...in certain states and cities within the United States . Final determinations with respect to… more
- New York State Energy Research and Development Aut (New York, NY)
- …senior attorney (the "MD-L&R") to join its management team, lead its Legal & Regulatory Affairs ("LRA") team and provide legal advice and strategic counsel with ... being directly responsible for a variety of legal and regulatory affairs activities and deliverables at the...or university and admitted to practice law in a US jurisdiction for at least ten years. If bar… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo ... for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US ,...pharmaceutical industry + 7 or more years with direct regulatory affairs experience + Experience in … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and… more
- Merck (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This ... + Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that...in certain states and cities within the United States . Final determinations with respect to… 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
- Mount Sinai Health System (New York, NY)
- …faculty. InCHOIR faculty are expert in study design, clinical coordination, regulatory approval and management, endpoint and event adjudication and Data Safety ... in federal and industry funding. This position is responsible for translating regulatory knowledge relating to human research, including federal, state, local and… more
- AbbVie (Florham Park, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is ... responsible for the management of global regulatory leads with product and disease state expertise for...in at least 2 regions in addition to the US (UK, EU, JAPAC, etc.) + NOTE: Higher education… more
- Actalent (Branchburg, NJ)
- Job Summary Under the general guidance of the Director Regulatory Affairs , Regulatory Affairs Associate plays a crucial role in ensuring the quality, ... and accuracy of drug product submissions to regulatory authorities. Some of the key functions include ensures...30,000 consultants and more than 4,500 clients across the US , Canada, Asia and Europe, Actalent serves many of… more
- Mount Sinai Health System (New York, NY)
- …of CMO - MSH, Mount Sinai Hospital **Responsibilities** In collaboration with Senior Director of Regulatory Affairs , and other system leadership, directs ... **Job Description** A member of MSHS regulatory team, the Accreditation Specialist is a key...trends, practices, and developments. Other duties as assigned. **About Us ** **Strength Through Diversity** The Mount Sinai Health System… more
- Bayer (Whippany, NJ)
- …well as executives in Marketing, Sales, Manufacturing, Drug Safety, Quality Assurance, Regulatory Affairs and Legal Departments; + The incumbent participates ... hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon… more