- Merck (Rahway, NJ)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... drive our strategic priorities. The Director, Principal Scientist | Regulatory Affairs Liaison is responsible for development...by regulatory agencies. + Functions as global regulatory lead assigned to programs where the… more
- Bausch Health (Bridgewater, NJ)
- …drive our collective progress and impact. Responsibilities: + Manages or represents Regulatory Affairs on the US promotional review committees for prescription ... of market promotional and advertising strategies. + Updates the Regulatory Affairs advertising and promotion staff, review... advice, response to FDA action letters, and helps lead the company in discussions with OPDP. + Implements… more
- Novo Nordisk (Plainsboro, NJ)
- …difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to ... The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global...Registrations Labeling Tools: + Serve as a subject matter expert in all labeling tools (SPL, TVT, Veeva Vault,… more
- BlackRock (New York, NY)
- …security, financial technology, and critical infrastructure. This role is for a Director of Regulatory Affairs on the US Government Affairs & Public Policy ... role** BlackRock has a long history as a trusted, expert resource to governments and policymakers around the world...world on financial markets policy. Since 2009, the Government Affairs & Public Policy team has steadily established the… more
- Bausch + Lomb (Trenton, NJ)
- …degree preferred (or equivalent education and experience). Minimum of 6 years in Regulatory Affairs or relevant experience in a regulated environment. Excellent ... promote a successful product regulatory strategy and increase probability of regulatory approval + Actively lead and/or participate in project team… more
- Merck (Rahway, NJ)
- …Development Execution, The primary function includes coordinating various GRACS (Global Regulatory Affairs and Clinical Safety) functional areas, to ensure ... implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements. These agreements include but are not… more
- BlackRock (New York, NY)
- …security, and investment in critical infrastructure. This role is for a Vice President, Regulatory Affairs on the US Government Affairs & Public Policy ... has a long history of service as a trusted, expert resource to governments and policymakers around the world....governments and policymakers around the world. Since the Government Affairs & Public Policy team was created in 2009,… 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 ... disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT)...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… 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 ... Description: Subject matter expert in the area of Biologics. Promotes and...strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits… more
- Taiho Oncology (Princeton, NJ)
- …such as: Clinical Development, Commercial, Evidence and Value Development, Market Access and Regulatory Affairs to ensure, as needed, alignment and inputs + ... indications. Position Summary: + The Sr. Medical Director, Medical Affairs (SMD, MA) needs to be an expert...clear understanding of all areas and functions within medical affairs and able to lead strategic development… more
- Novo Nordisk (Plainsboro, NJ)
- …across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates, ... collaboration - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, International Operations, NN International +… more
- Bristol Myers Squibb (Madison, NJ)
- …Research and Development, Regulatory , Translational Development, and Market Access, and will lead the US Medical asset strategy supporting the MM lead and ... and other cross-functional teams. + Represent US Medical Affairs as a therapeutic area expert in...for key late stage asset(s) entering the market + Lead /support various Medical Affairs cross-functional working groups.… more
- Sumitomo Pharma (Trenton, NJ)
- …and responses to unsolicited requests for medical/scientific information. + Serves as Medical Affairs Lead on select therapeutics topics, and provides input into ... Products, pre-, and post launch activities related to Medical Affairs function. This individual will lead program...Product Development Monthly Meetings. + Serve as Subject Matter Expert within Medical Affairs Team provide medical… more
- Sanofi Group (Bridgewater, NJ)
- …what you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the fully accountable ... **Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ...in R&D, including at least 10 years of relevant Regulatory Affairs experience (regionally and/or global), in… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... strategies are in alignment with product portfolio, regional strategies, CMC- Regulatory Affairs strategy, commercial and market access strategy, and… more
- Haleon (Warren, NJ)
- …eDMS, onsite and offsite storage); serve as official point of contact as US Regulatory Affairs (USRA) Administrator for Veeva Vault and any other systems needed; ... functional team on technology solutions and serve as process expert on implementation + **FDA Reporting Lead :**...**Basic Qualifications:** + Minimum 8 years of experience in Regulatory Affairs , Medical Affairs , Consumer… more
- J&J Family of Companies (Titusville, NJ)
- …+ Write or provide guidance to other writers on all types of clinical, regulatory , and safety documents, taking a proactive lead in content and scientific ... applicable), and teams. + Ability to delegate responsibility to other medical writers. + Expert ability to lead and influence by example and stay focused… more
- J&J Family of Companies (Raritan, NJ)
- …for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Writing **Job Category:** Professional ... - 920 US Hwy 202 **Job Description:** **Manager, Oncology Regulatory Medical Writing** At Johnson & Johnson Innovative Medicine,...Prepare and finalize all types of clinical documents. + Lead in a team environment. Work with a high… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Global Medical Expert , nirsevimab **Location** : Bridgewater, NJ / Morristown, NJ **About the Job** Under the supervision of the Global Medical Brand ... Lead , nirsevimab, provide medical strategic advice/expertise for the Sanofi...the medical insights + Provide medical input to all regulatory and pharmacovigilance activities related to lifecycle management of… more
- Sanofi Group (Bridgewater, NJ)
- …Provide medical input for the definition of and alignment with the Franchises & Regulatory Affairs strategies for Marketed products + Support priority markets in ... **Job title** : Global Medical Product Lead (Recombinant Influenza Vaccine) **Location:** Bridgewater, NJ **About the Job** Sanofi Vaccines is the Global Business… more