- Bristol Myers Squibb (Princeton, NJ)
- …and implementing comprehensive cGMP training programs to ensure compliance with global regulatory standards. + Job-Specific Training: Providing targeted ... alignment with Bristol Myers Squibb (BMS) policies, standards, procedures, and global current Good Manufacturing Practices (cGMPs). In this capacity, the incumbent… more
- Taiho Oncology (Princeton, NJ)
- …clinical development experience is preferred. + Direct work experience with US and/or Global Regulatory authorities is highly preferred. + Highly detail and ... guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are… more
- embecta (Parsippany, NJ)
- …maintaining regulatory compliance, and driving process improvements across embecta's global operations. As an integral part of the Quality Systems team, the ... changes, internal audits, or process improvements. + Ensure documentation adheres to global medical device regulatory requirements, including FDA 21 CFR Part… more
- Coinbase (Trenton, NJ)
- …Familiarity with privacy laws specific to financial institutions (eg GLBA) and the global financial regulatory frameworks (eg AML/KYC compliance, PSD2). CIPP or ... emerging onchain platform - and with it, the future global financial system. To achieve our mission, we're seeking...and Trust & Risk to respond to privacy incidents, regulatory inquiries, law enforcement demands, and other information requests.… more
- Bristol Myers Squibb (Summit, NJ)
- …compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements. + Drive completion, adherence to training ... conditions while maintaining appropriate level of controls and compliance with regulatory requirements. + Flexible with the ability to adapt, respond quickly… more
- Cytel (Trenton, NJ)
- …(including machine learning), with experience across all phases of development and global regulatory interactions. We are seeking an **Executive Consultant** - ... Cytel at conferences, webinars, and industry publications to strengthen Cytel's global visibility and reputation. + Support multidisciplinary internal teams with… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …performance and safety reporting requirements for medical devices to align with global regulations. + Support regulatory submissions towards EU MDR requirements, ... to new product development activities, marketing initiatives, quality assurance and regulatory product requirement support. Clinical input is expected towards the… more
- Bristol Myers Squibb (Princeton, NJ)
- …standing experience in all phases of research and drug development, including global regulatory submissions (IND/CTA through NDA/BLA/MAA/JNDA/ NDA China) and ... to high priority development asset(s). They operate as a strategic partner to the Global Program Lead (GPL), to shape and deliver the Target Product Profile (TPP)… more
- Bristol Myers Squibb (Princeton, NJ)
- …mechanisms with focus on Omnichannel & AI team outcomes. + Ensure US and global regulatory , privacy, and data governance standards are harmonized and embedded, ... effective communication, and facilitates the execution of strategic priorities across the global Omnichannel & AI organization. As a dynamic leader, the Director… more
- Ascendis Pharma (Princeton, NJ)
- …validated Drug Safety Databases (Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Expert knowledge of FDA ... safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global ...applicable regulatory guidance documents; working knowledge of global safety regulations. + Ability to travel up to… more