- Takeda Pharmaceuticals (Lexington, MA)
- …interacting with senior internal and external personnel. Provide validation expertise to regulatory affairs when responding to governmental regulatory ... bodies. Up to 5% domestic travel required. Up to 40% remote work allowed. **REQUIREMENTS:** Bachelor's degree in Industrial Chemical Engineering, Chemical Engineering, or related field, plus 7 years of related experience. Prior experience must include: prepare… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Medical IISR clinical trials in assigned TA. Ensure coordination with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from ... Research and program management experience working with clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug development… more
- Actalent (Boston, MA)
- …PharmD, or PhD preferred. + Minimum of 8+ years of experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, DSURs, and agency ... Job Title: Director Regulatory CMC Job Description We are seeking a creative and agile regulatory professional eager to join a collaborative team as a… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing. + ... Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development… more
- Beth Israel Lahey Health (Boston, MA)
- …+ Bachelor's degree in Life Science or related field required; Master's degree in Regulatory Affairs preferred. + Minimum of 3-5 years related work experience ... taking a job, you're making a difference in people's lives.** The Sr. Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel… more
- Sanofi Group (Cambridge, MA)
- …Clinical Research Director, Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs , Biostatistics, Clinical Study Units, Medical ... to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and cross-functional… more
- Takeda Pharmaceuticals (Boston, MA)
- …assessment document + Engages with partner global functions (eg Clinical Science, Med Affairs , Regulatory Affairs , Biostats) to ensure alignment of global ... position for pharmacovigilance risk management processes to maximize patient safety + Provide strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. + Support… more
- Commonwealth Care Alliance (Boston, MA)
- …+ Interdepartmental stakeholders include but are not limited to: quality; regulatory affairs /compliance; clinical, operations, pharmacy, dental, reporting, and ... member services. + Supports the Senior Appeals & Grievance Coordinator and A/G Coordinator in day-to-day tasks and assignments. Content Expert: + Act as CCA's content expert on State and Federal Grievance and Appeal regulations for all CCA products. +… more
- Merck (Boston, MA)
- …immunology, neurology, cardiometabolic and others as needed by the pipeline. + Work with Regulatory Affairs to ensure that regulatory documents (eg, IDEs, ... stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development,… more
- Bayer (Cambridge, MA)
- …(GCL), with input from and consensus with groups such as Research, Early Development, Regulatory Affairs , and commercial functions; + Serve as an internal expert ... in Target ID teams or early research teams, providing medical/clinical expertise to identify and assess intended indications, patient (sub)populations, and drug targets within Bayer's strategic framework; + Provide early clinical development concepts or plans… more