- 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 ... and Planning Leader will play a pivotal role in advancing Global Regulatory Affairs (GRA's) mission by providing cross-TA support for planning, execution, and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. **EXAMPLE RESPONSIBILITIES:** + As needed, represents ... regulatory strategies, processes, standards, practices, efficiencies and capabilities. + Represents Regulatory Affairs and may serve as Regional Lead or… 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 ... is preferred. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs , Clinical, Medical Information, Pharmacovigilance, etc.) is required.… more
- J&J Family of Companies (Raritan, NJ)
- …profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, Regulatory Affairs , CMC Regulatory Affairs , Product Artwork, and… more
- J&J Family of Companies (Titusville, NJ)
- …assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global ... adverse events (pre and post-marketing) for relationship to treatment** **Assists Regulatory Affairs in determining requirements for any corrective actions… more
- Sanofi Group (Morristown, NJ)
- …+ Monitor regulatory trends and implement timely updates in coordination with Regulatory Affairs and local markets. + Track and resolve non-compliance issues ... & Team Management** + Collaborate with senior leaders and stakeholders across Regulatory Affairs , Quality Assurance, Manufacturing & Supply, Commercial, and… more
- Merck (Rahway, NJ)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Pulmonary Disease Research, Pulmonary Disease Treatment, Pulmonary Disorders, Pulmonology, Regulatory Affairs Compliance, Regulatory Compliance, Scientific… more
- Sumitomo Pharma (Trenton, NJ)
- …budget for Oncology clinical development activities. + Partner with Translational Research, Regulatory Affairs , Clinical Operations, and Medical Affairs to ... submissions, clinical study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with regulatory requirements. **Key… more
- Merck (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5 more} **Preferred… more
- Astrix Technology (Monmouth County, NJ)
- …quality standards. + Collaborate with cross-functional teams including drug safety, regulatory affairs , clinical development, and biostatistics. + Interpret and ... experience in medical writing with a focus on pharmacovigilance or regulatory affairs . + Strong knowledge of drug safety regulations and pharmacovigilance… more