- Takeda Pharmaceuticals (Boston, MA)
- …guidelines. Provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory requirements. Serve as the expert for ... (MSc, PhD, or PharmD) preferred. + 8+ years of pharmaceutical industry experience. This is inclusive of 6 years...product labeling (ie CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations… more
- Merck (Cambridge, MA)
- …leverage advanced computational modeling and simulation tools to support pharmaceutical researchers in predicting drug behavior, improving decision-making, and ... experts as necessary to facilitate progress. + Actively participate in regulatory audits and inspections in close collaboration with business stakeholders and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and Aspects:** **Technical/Functional (Line) Expertise:** + Comprehensive understanding of the pharmaceutical industry and medical affairs + Global regulatory ... collaboration with cross-functional teams (including Medical Affairs, Clinical Development, Regulatory Affairs, Commercial, GPD comms), to ensure alignment and… more
- Actalent (North Billerica, MA)
- …will manage and contribute to CMC-related projects and initiatives, ensuring compliance with regulatory , scientific, and technical criteria. Responsibilities + ... in the pharmaceutical industry with strong skills in authoring CMC regulatory sections, including INDs/CTAs. Additional Skills & Qualifications + BS in a life… more
- Bristol Myers Squibb (Devens, MA)
- …& Experience** **Specific Knowledge, Skills & Abilities:** + Expertise in GMP compliance , global regulations and strong understanding of pharmaceutical product ... Demonstrated decision making and problem-solving capabilities relative to Quality, compliance , technical considerations, and regulatory requirements are… 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...Medical Affairs, Market Access, Omnichannel, Patient Marketing, Legal, and Regulatory to ensure unified execution and strategic cohesion. +… more
- Bayer (Cambridge, MA)
- …833156 **Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Medical Research, Clinical Research, Compliance , Law, Pharmaceutical , Healthcare, Legal, ... in management of interactions with KOLs as well as with regulatory authorities will work closely with Pharmacokinetics specialists, Translational Sciences,… more
- Nanobiosym, Inc. (Cambridge, MA)
- …knowledge of applicable regulations, providing consultation to staff regarding regulatory compliance . Qualifications Qualifications * Minimum 8 years' ... (Clinical Laboratory Improvement Amendments) Quality Manager will provide quality and compliance oversight to the Nanobiosym diagnostic testing laboratory.T his is a… more
- Chiesi (Boston, MA)
- …inform internal decision making. + Conduct engagements in adherence with legal, compliance and regulatory guidelines to ensure Chiesi Rare Diseases relationships ... self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a...and externally. + Understanding of drug research and development, regulatory , compliance and disclosure guidelines. + Strong… more
- Chiesi (Boston, MA)
- …clinical trial awareness, etc. + Conduct engagements in adherence with legal, compliance and regulatory guidelines to ensure Chiesi Rare Disease relationships ... self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a...function. + Understanding of drug research and clinical development, regulatory , compliance and disclosure guidelines. + Strong… more