- Organon & Co. (Jersey City, NJ)
- … strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation ... Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and ... while balancing business benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee submission planning, authoring, reviewing,… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral and written communication ... Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …establish Regulatory Requirements. + Support development and execution of global regulatory strategies by collaborating closely with international ... regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA and other global regulatory agencies and experience negotiating with regulatory authority personnel… more
- Sumitomo Pharma (Trenton, NJ)
- …**Director, Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...function as the Regulatory reviewer for assigned products. This position is responsible… more
- City National Bank (Trenton, NJ)
- …into the regulatory relations application, referred to as GRRID ( Global Regulatory Relations Information Database) are accurately and consistently captured. ... compliance. * Support the implementation of GRRID and ensuring alignment with global regulatory requirements. * Will support the team that works with business… more
- System One (Florham Park, NJ)
- …market intelligence to provide background insights. + Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies and Submissions ... with Global Development Plans and Regulatory Strategy Plans ESTABLISH DELIVERABLES & PERFORMANCE EXPECTATIONS + Preparation of Type C/B/D Meetings for antivirals… more
- System One (Florham Park, NJ)
- …with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (eg, IND, ... Job Title: Regulatory Operations Senior Publisher - Contractor Location: Florham...will support in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic… more
- Actalent (Piscataway, NJ)
- …and ensure the seamless management of lab documentation and sample processes within global regulatory compliance. This role requires a leader who can guide ... environment. Responsibilities + Manage lab documentation for samples ensuring compliance with global regulatory standards. + Provide guidance and leadership to… more
- J&J Family of Companies (Raritan, NJ)
- …+ Configuration experience with Veeva RIM product suite + Knowledge of global regulatory affairs, regulations, computer systems validation requirements, current ... converting them into functional and IT requirements + Excellent understanding of Global Regulatory Affairs systems, processes, and system/data integrations with… more