- Colgate-Palmolive (Piscataway, NJ)
- …to achieve project goals + Manage requirements involving legal agreements, IP, regulatory , safety and quality **Required Qualifications:** + Ph.D. in cell biology, ... immunology, molecular biology, biochemistry or biomedical engineering, or a related field + Hands on experience with primary cell culture/tissue culture + Knowledge of dermatology and/or skin biology + Hands on experience with quantitative PCR,… more
- Merck (Trenton, NJ)
- …stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development, ... to stay up to date regarding industry trends and diagnostic regulatory requirements. **Essential Job Requirements:** + Develop end-to-end diagnostic strategy in… more
- Sumitomo Pharma (Trenton, NJ)
- …Team. + Collaborate with the process and analytical development, quality, and regulatory functions to establish a robust, compliant clinical supply chain to support ... company objectives. + Champion regulatory and technical documents for regulatory submissions...domestically and international if/when needed. **Education and Experience** + PhD or MS Chemistry, Biology, or related field is… more
- BD (Becton, Dickinson and Company) (Branchburg, NJ)
- …the Site Lead will gather and share insights from customer projects and regulatory interactions to influence the product roadmap and shape our messaging strategy in ... + Drives continuous improvement, efficiency, and compliance with all applicable regulatory and quality standards. + Manages site facilities and infrastructure to… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …manufacturing equipment. This role is critical to ensuring compliance with regulatory standards and maintaining the highest levels of cleanliness and safety ... evaluation and feedback of methods. + Ensure compliance with regulatory requirements (eg, FDA, EMA) and industry standards (eg,...or Masters degree and 6-9 years of experience, or PhD and 4-6 years of experience + Extensive pharmaceutical… more
- Merck (Rahway, NJ)
- …vaccine bioanalytical outsourcing, ensuring alignment with corporate objectives and regulatory requirements. The Senior Director will oversee a multidisciplinary ... teams, including research and development, regulated bioanalytical, clinical research, regulatory affairs, and quality assurance, to provide scientific leadership… more
- Sanofi Group (Morristown, NJ)
- …who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an ... in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim to… more
- Merck (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory environment… more
- Merck (Rahway, NJ)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ ... to designing and analyzing clinical trials in support of worldwide regulatory submissions. This position involves interaction with Medical, Data Coordination,… more
- Sanofi Group (Morristown, NJ)
- …possible. Ready to get started? **Main Responsibilities:** + Develop CMC regulatory strategies and assess associated risks for development projects and/or registered ... products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities. + Participate in Change Control assessment. + Guarantee… more