- Daiichi Sankyo, Inc. (Bernards, NJ)
- …advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, ... science and technology. With more than 120 years of scientific expertise and a presence in more than 20...and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing… more
- UTMB Health (Galveston, TX)
- …will serve as the single point of study control with overall responsibility for the scientific , technical and regulatory conduct of studies as well as for the ... with the Scientific Director for the Institutional Office of Regulated Nonclinical Studies (ORNcS), study sponsors and/or funding agencies to design and execute… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … strategies for assigned programs and ensures cross-functional alignment. + Leads regulatory activities within the project teams ( nonclinical , clinical) to ... regulatory submissions relevant to assigned programs, including coordinating regulatory workflow, reviewing technical documents ( nonclinical , clinical, and… more
- J&J Family of Companies (Spring House, PA)
- …anonymization policies and procedures across JRD. + Management of Data Transparency Regulatory Document associates. + Development and improvement of global ... ( document anonymization), Industry Associations (shaping industry practice and regulatory publication policies). _Are you interested to join our team? Then… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, ... science and technology. With more than 120 years of scientific expertise and a presence in more than 20...and immune disorders. **Job Summary:** The Associate Director of Regulatory Writing is a key role responsible for producing… more
- Bristol Myers Squibb (Summit, NJ)
- …setting, decision making, and quality oversight to ensure BMS complies with regulatory requirements. + Previous experience dealing with regulatory agencies in ... simplicity. Keen focus on phase appropriate and risk based scientific decision making + Creates a vision for the...and author the overall Quality Narrative (or equivalent) to document the end to end risk based quality management… more
- Takeda Pharmaceuticals (Boston, MA)
- …Cambridge, MA with the following requirements: Master's degree in Pharmaceutical Sciences, Regulatory Affairs or related field plus 2 years of related experience. ... Prior experience must include: Knowledge of global regulatory guidelines, and understanding of Good Documentation Practices (GDP), Good Manufacturing Practices… more
