- Bristol Myers Squibb (Summit, NJ)
- …with proven expertise in S&OH risk assessment, high hazard work, investigations and regulatory compliance . A key focus will be on EHS database management, ... Safety & Occupational Health (S&OH) Manager with a strong background in the pharmaceutical or life sciences industries to lead and enhance our site-wide S&OH… more
- Actalent (Basking Ridge, NJ)
- …with internal procedures. The role involves coordinating labeling projects to ensure regulatory compliance and providing guidance to team members on labeling ... files according to internal procedures. + Coordinate labeling projects to ensure regulatory compliance . + Provide guidance on labeling regulations and process… more
- Actalent (Basking Ridge, NJ)
- …processes related to labeling updates. + Coordinate labeling projects to ensure regulatory compliance . + Facilitate project completion through effective and ... + Ability to partner with members across departments like Regulatory and Quality to ensure compliance . +...a scientific discipline. + 1-3 years of experience in pharmaceutical manufacturing. + 1-2 years of quality experience with… more
- Cytel (Trenton, NJ)
- …& Compliance :** + Ensure all processes and deliverables meet regulatory requirements and internal quality standards. + Support audit readiness and continuous ... others to do the same. Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at… more
- Sumitomo Pharma (Trenton, NJ)
- …Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- Merck (Trenton, NJ)
- …In-depth expertise in local regulatory frameworks, ethical standards, and pharmaceutical compliance requirements. + Proven capability to cultivate and ... Team Leadership, Executive Leadership, Healthcare Delivery Systems, Medical Affairs, Pharmaceutical Compliance , Scientific Communications, Scientific Exchange, Strategic… more
- Hovione (East Windsor, NJ)
- …physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP ... as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market. Our people… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support, ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- Sokol Materials & Services (Skillman, NJ)
- …+ Strong interest in pursuing a career in CQV within the pharmaceutical , biotechnology, or medical device industries. + Excellent organizational skills and attention ... service providers, you will ensure that critical CQV activities align with regulatory standards and best practices. This role requires a professional with analytical… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …existing CDMOs. + Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust ... appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Operations to align strategies and optimize product… more