- Grifols Shared Services North America, Inc (Worcester, MA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions… more
- Takeda Pharmaceuticals (Boston, MA)
- …for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and ... and digital health efforts for assigned programs.. + Ensures global regulatory plans effectively accommodate appropriate precision medicine approaches by effectively… more
- Takeda Pharmaceuticals (Boston, MA)
- …GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member on ... Regulatory , Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff.… more
- Rhythm Pharmaceuticals (Boston, MA)
- …to overcome barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development ... and delivery of science-based, solution-oriented and internally aligned regulatory strategies for the program(s) under your accountability. You will lead the … more
- Olympus Corporation of the Americas (Westborough, MA)
- …at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical ... in the markets served by Olympus. **Job Duties** + Facilitate development of regulatory strategy for novel technologies or market segments, that lead to product… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Objective / Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across Takeda's development ... technology portfolio, encompassing Clinical Development, Regulatory Affairs, and Pharmacovigilance domains. This role is accountable...regulations (eg, GxP, 21 CFR Part 11, ICH, EMA, FDA , PMDA) and Takeda's quality and risk management standards.… more
- Actalent (Cambridge, MA)
- Description * Support line manager with the day-to-day management of regulatory aspects of at least one clinical development program * Responsible for relevant ... submissions for assigned program(s). * Represent the Global Regulatory Sciences function on cross functional teams * Support...* Ideally experienced in filing and managing INDs to FDA * Working knowledge of drug development process and… more
- Chiesi (Boston, MA)
- …Direct global early access and compassionate use programs, ensuring compliance with varied regulatory frameworks (eg, FDA , EMA, and other health authorities). + ... narratives for global stakeholders. + Partner with R&D, clinical development, regulatory , and commercial teams to ensure seamless, consistent messaging across all… more
- ThermoFisher Scientific (Plainville, MA)
- …2-3 years experience leading teams in a fast-paced environment required. + Experience with regulatory inspections from the FDA , EMA, Health Canada, or other ... and drive efficiency throughout the organization. + Support internal, external, and regulatory inspections as needed. + Hire and develop employees within the… more
- Abbott (Burlington, MA)
- …system improvement activities. + Comply with US Food and Drug Administration ( FDA ) regulations, EUMDR, and other regulatory requirements and Abbott policies, ... or an equivalent combination of education and experience. + Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304),… more