- Amneal Pharmaceuticals (Piscataway, NJ)
- …The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical / FDA Communications.Assists the Senior ... communications/ updates Essential Functions: + Assist the Senior Director of Clinical Regulatory Affairs / FDA Communications in managing, coordinating,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …(eCTD) format. + Experience with international clinical trials and regulatory documentation. + Experience interacting with FDA representatives and organizing ... on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs (Early Development) provides strategic global regulatory … more
- Merck (Rahway, NJ)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... drug development or clinical experience, preference if this experience is in regulatory affairs . + Excellent communication skills (both oral and written). +… more
- Actalent (Bridgewater, NJ)
- …Title: Head of Regulatory AffairsJob Description We are seeking a Head of Regulatory Affairs to be based in Bridgewater, NJ. Reporting to the Chief ... regulatory strategy. The position will lead the regulatory affairs and operations team and partner...company's key corporate liaison, maintaining strong professional relationships with regulatory agencies, especially the FDA and EMA.… more
- Novo Nordisk (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... About the Department The Clinical , Medical and Regulatory (CMR) department...and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …for assigned cell and gene therapy portfolios. This role includes overseeing regulatory affairs staff, various outside contractors, supporting project teams and ... typical day might include:** + Direct activities of assigned Regulatory Affairs team with emphasis on global...and the preparation, review, and submission of documents for FDA , EMA and other regulatory authorities. +… 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 ...if:** + If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process,… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …activities. + Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial ... and approval is a distinct advantage. + Experience in dealings with FDA and other regulatory authorities. To be considered for this opportunity, you must have at… more
- Bayer (Whippany, NJ)
- …guidance and category knowledge to US Medical Strategy, Marketing, New Development, US Regulatory Affairs , Communications, Legal and Global Medical Affairs ... press releases; + S/He will contribute to post approval regulatory required trials by the FDA . This...Imaging or Breast Cancer is required; + Experience in clinical research and development or medical affairs … more
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Catalent Pharma Solutions (Somerset, NJ)
- …NJ is hiring a Senior Regulatory and Compliance Specialist for the Regulatory Affairs Group. The Senior Regulatory and Compliance Specialist candidate ... Assurance, Pharmaceutical Manufacturing, or Compliance + Knowledge of US FDA regulatory requirements as it pertains to...a regulated field is required + Deep understanding of FDA and cGMP regulations pertaining to clinical … more
- System One (Florham Park, NJ)
- …+ Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance ... Operations Associate Contractor will lead in the preparation and submission of electronic regulatory documents through the FDA , EMA, MHRA, and Health Canada… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Operations, Chemistry, Manufacturing and Controls (CMC), Product Quality Assurance (PQA), Regulatory Affairs and Sourcing departments. + Identifies suitable ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and...any current or potential new CPOs. + Collaborates with Regulatory Affairs to provide all documents required… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development functions, ensures that all ... aspirations. Join Gilead and help create possible, together. **Job Description** ** CLINICAL OPERATIONS:** Clinical Operations is responsible for the execution… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety &...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Novo Nordisk (Plainsboro, NJ)
- …Internal stakeholders: Global Safety, QPPV office, Global Development, Product Supply, Regulatory Affairs (NNI/NNCI) marketing, legal and NNI Patient Support ... About the Department The Clinical , Medical and Regulatory (CMR) department...the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- Terumo Medical Corporation (Somerset, NJ)
- …work with stakeholder departments such as Engineering, Operations, Clinical , Medical Affairs and Regulatory Affairs on Post Market Surveillance strategy ... products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part… 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 ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more