- Cambrex High Point (Waltham, MA)
- …NMR, TGA, DSC, particle size analyzer etc. to characterize and quantitate pharmaceutical synthetic molecules. Knowledge of regulatory guidelines and experience ... 1+ years of experience in analytical chemistry within the pharmaceutical industry. The candidate should have a broad experience...Author and review analytical protocols, reports, and SOPs in compliance with GMP and regulatory expectations. +… more
- Cognizant (Boston, MA)
- …advanced degree preferred. Certifications: (Optional) ISTQB, PMP, or relevant regulatory compliance certifications. **_Roles & Responsibilities_** Develop and ... transformation and paperless execution. . Collaborate with project stakeholders, including regulatory and compliance teams, to establish Validation and testing… 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 in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma… more
- Takeda Pharmaceuticals (Lexington, MA)
- …IIR within assigned TA in accordance with all applicable internal legal and compliance policies as well as external US-specific regulatory guidelines. + Partners ... development (eg, thru Patent Exclusivity expiration). + Thorough understanding of legal, compliance , and regulatory guidelines related to the conduct of a… more
- Sumitomo Pharma (Boston, MA)
- …during IND submissions, clinical study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with regulatory ... 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
- 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...Collaborate with the process and analytical development, quality, and regulatory functions to establish a robust, compliant clinical supply… more
- Baystate Health (Springfield, MA)
- …in compliance with the departmental policies and procedures including regulatory compliance measures. Understands the basic modes of delivery (pneumatic ... changes in clinical practice guidelines, new medication therapy, etc. **6)** Regulatory Compliance : Documents and manages controlled substances in accordance… more
- Sumitomo Pharma (Boston, MA)
- …and aggregate safety reports + Knowledge of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements + ... 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …method validation and implementation activities for drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and ... collection, storage conditions, and analytical testing, to support product development and regulatory submissions. + Author and review INDs, NDAs, and other … more
- Sumitomo Pharma (Boston, MA)
- …with brand strategy and market access goals. + Collaborate closely with **legal, compliance , privacy and regulatory teams** to ensure program design and ... 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