- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** **Responsibilities** + Work closely within the Regulatory Affairs function to identify process opportunities & gather ... to enhance Automation and AI skills (including Microsoft Work package) across Regulatory Affairs organization. + Share knowledge and best practices within… more
- Parexel (Trenton, NJ)
- …go-to expert for global labeling, working side-by-side with client teams across Regulatory Affairs , Technical Operations, Safety, and Commercial. You'll help ... This role is ideal for a candidate with a strong background in regulatory affairs , labelling strategy, and cross-functional leadership. It offers the opportunity… more
- Parexel (Trenton, NJ)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... leads in developing contingency plans for CMC-related scenarios - Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory… more
- embecta (Parsippany, NJ)
- …market new or modified devices in both the US and Europe, and related regulatory affairs activities to ensure compliance with regulations and alignment with the ... objectives of the business. This role will also represent regulatory affairs and provide leadership across multiple project development teams by interpreting and… more
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate Principal Scientist is responsible for?developing and?implementing… more
- Terumo Medical Corporation (Somerset, NJ)
- …stakeholders, to include Clinical Affairs , Professional & Clinical Education, Regulatory Affairs , Quality Systems, Marketing, Sales as well as external ... documents and scientific presentations in cooperation with the Clinical, Medical, & Regulatory Affairs Teams, Key Opinion Leaders and physician investigators. +… more
- Terumo Medical Corporation (Somerset, NJ)
- …organization that includes Medical Affairs , Clinical Operations, Sales, Marketing, Regulatory Affairs , to ensure maximum exchange of information and ... launch meetings. + Regulatory activities partnership: + Work with regulatory affairs to ensure that all written documents are scientifically accurate and in… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of...Manufacturing and Controls (CMC), medical affairs and business development are critical to the success… more
- Organon & Co. (Jersey City, NJ)
- …of industry experience? in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least ... three years of experience in project management. + Proficient with MS Project, MS Timeline, and all Office products. + A working understanding of and application of principles, concepts, practices, and standards of pharmaceutical project management. + Worked… more
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal Scientist is… more
