- 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
- Merck (Rahway, NJ)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help… more
- Merck (Rahway, NJ)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented...to facilitate initial approval by agencies for conduct of clinical trials + Participate in regulatory due… 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
- Stryker (Mahwah, NJ)
- …**Preferred** + RAC certificate and/or Advanced Degree (Masters in Regulatory Affairs ) preferred + Knowledge of FDA and international medical device ... regulatory agencies and notified bodies. The Senior Regulatory Affairs Specialist is the Regulatory...for responsible products/technical files + Author and submit electronic regulatory submissions for the FDA and Notified… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …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 (Tarrytown, NY)
- 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 (Tarrytown, NY)
- …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
- 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
- Hackensack Meridian Health (Neptune, NJ)
- …executed. + Works on special projects for Research department quality assurance, regulatory affairs and education sections, including review and submission of ... other relevant area of study. + Minimum of 6 or more years of experience in clinical research experience. + Working knowledge of FDA and DHHS regulations, Good … more
- Caris Life Sciences (New York, NY)
- …responsible for clinical data entry activities for the Caris Medical Affairs protocols and projects at the Caris Precision Oncology Alliance sites. The position ... clinical database. + Support and adhere to Good Clinical Practices (GCP) guidelines, FDA , Institutional Review...years of experience in data collection activities within a GCP/ clinical research regulatory environment. + Knowledgeable in… 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