- GRAIL (Trenton, NJ)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
- Bayer (Whippany, NJ)
- …diagnostic radiotracers and/or Theranostics) will be considered; + Proven experience with FDA regulatory requirements and ICH GCP guidelines for development (IND ... a real difference, there's only one choice.** **Director Global Regulatory Strategy (Molecular Imaging, Pharmaceuticals)** The position is responsible...submission, FDA formal meetings, etc). **Preferred Qualifications:** + Advanced technical… more
- Bristol Myers Squibb (Princeton, NJ)
- … FDA regulations and guidances. **Responsibilities include:** + Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical ... compliance of all promotions with approved labeling and /or FDA guidances + Ensure regulatory compliance with subpart E/H and 2253 regulations + Lead training… more
- J&J Family of Companies (Raritan, NJ)
- … regulatory health authorities (ie European Notified Body, BSI, European MDR, and FDA ). The Senior Regulatory Affairs Specialist helps to define data and ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
- ThermoFisher Scientific (Cranbury, NJ)
- …claims. + Author and/or review regulatory submissions, specifically device master files, regulatory support files, and meeting requests to FDA and other ... experience strongly preferred. **Knowledge, Skills, Abilities:** + Extensive knowledge of regulatory requirements, including those from the FDA , Health Canada,… more
- Sumitomo Pharma (Trenton, NJ)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... to support proposed claims and assess consistency of proposed claims with FDA -approved labeling + Provide regulatory leadership to the respective… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US ( FDA regulatory agencies),participate in audits ... clinical and medical standpoint, identify and respond to signal analysis, and submit to regulatory agency ( FDA /Health Canada) within timelines to achieve 100%… more
- Oracle (Trenton, NJ)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more
- Oracle (Trenton, NJ)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more
- Oracle (Trenton, NJ)
- …all device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's ... standards such as IEC 62304, IEC 82304, and relevant FDA guidance. + Proven ability to apply regulatory... FDA guidance. + Proven ability to apply regulatory requirements to software design, documentation, and development practices.… more