- Actalent (North Billerica, MA)
- …in the pharmaceutical industry. + Strong experience in authoring CMC regulatory sections. + Working knowledge of US regulatory regulations. Work Environment ... have an incredible opportunity with one of the leading pharmaceutical companies in the world. We are looking for...and develop strategic plans. + Ensure quality assurance and compliance with GMP standards, including change control, deviation, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs. + Advanced ... Lead in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company.… more
- Sumitomo Pharma (Boston, MA)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...collaboration with the Clinical Research Team. + Monitor protocol compliance including assessment of inclusion and exclusion criteria, patient… more
- Takeda Pharmaceuticals (Lexington, MA)
- …managers and scientists and their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with ... to Commercialization by collaborating with multiple functions within the Pharmaceutical Science organization to improve analytical, process and product knowledge.… more
- Sanofi Group (Framingham, MA)
- …technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded ... This critical role: + Covers all Lifecycle phases of pre-authorization to regulatory submission, submission to pre-approval inspection (PAI), PAI to launch, and… more
- Boehringer Ingelheim (Boston, MA)
- …to advance customer understanding, materials, and programs that enhance patient compliance , adherence, and fulfillment of BI's portfolio. Interacts with internal ... and implementation of in-depth patient and caregiver support programs to enhance compliance , adherence, and fulfillment of BI's specialty portfolio. Assists in the… more
- Sumitomo Pharma (Boston, MA)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...critical role in supporting the tax department in meeting compliance , provision, and planning goals. The position is primarily… more
- Takeda Pharmaceuticals (Boston, MA)
- …that support Takeda R&D programs across therapeutic areas** **Oversee and ensure compliance with internal policies, GxP standards, and regulatory requirements, ... cultures** **Demonstrated ability to prioritize, manage multiple programs within strict regulatory and compliance deadlines, and lead internal/external and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …medical device, digital health, and AI clients on the application of healthcare regulatory laws to their business. The position will report to the Executive ... inside and outside the department. All members of OPH Legal and Compliance must exemplify collaborative culture and drive joint accountabilities across multiple… more
- Sumitomo Pharma (Boston, MA)
- …in biotech or pharmaceutical drug development. + Experience in interaction with regulatory agencies such as the FDA, EMA/CPMP, PMDA, or others. + Experience in ... 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