- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… more
- Sanofi Group (Morristown, NJ)
- …that model the Sanofi and GRA Values/Principles/Competencies. + Oversees the development of CMC regulatory strategy and regulatory risk assessments for all ... including directly with FDA and EMA, so that appropriate and pragmatic Regulatory CMC positions are negotiated with the highest Probability of Success (POS).… more
- Taiho Oncology (Princeton, NJ)
- …Join our dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director, Regulatory CMC ... Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology Inc., (TOI)… more
- Sumitomo Pharma (Trenton, NJ)
- …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global … more
- Adecco US, Inc. (Morristown, NJ)
- Adecco Healthcare & Life Sciences is seeking a skilled ** CMC Regulatory Technical Writer II** to support a global pharmaceutical client in lifecycle management ... relevant experience level **Key Responsibilities:** + Author and develop CMC sections of regulatory dossiers (Modules 2 and 3) for development and post-approval… more
- Sanofi Group (Morristown, NJ)
- …in early and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated experience with preparation ... **Job Title:** Regulatory Strategist **Location** : Cambridge MA/ Morristown, NJ...accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global… more
- Parexel (Trenton, NJ)
- …country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life ... DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely,… more
- Merck (Rahway, NJ)
- …(DCT) leader is accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen… more
- Atlantic Health System (Pompton Plains, NJ)
- …revision of procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP, ... TJC, OSHA. 5. Maintains clear, real time communications shift-to-shift and with leadership regarding issues, concerns and problems which may affect patient care or the operation of the department. 6. Participates in planning and implementing change through… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more