- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Takeda Pharmaceuticals (Boston, MA)
- …of regulatory submissions. + Expert knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a ... + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… more
- Philips (Cambridge, MA)
- …right fit if:** + You've acquired a minimum of 7+ years' experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments. + You have ... The Principal Regulatory Affairs Specialist will develop and execute the...EUMDR tech files, and Pre-Sub notifications submitted to the FDA . + Your skills include familiarity with FDA… more
- Takeda Pharmaceuticals (Boston, MA)
- …for Late-Stage assets. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a ... patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part...a professional and timely manner. + Accountable for US FDA submissions and approvals of project(s) of responsibility. May… more
- Takeda Pharmaceuticals (Boston, MA)
- … and/or related experience. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a must. Knowledge of EU, ... on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of...lead as a member of a GRT + Primary FDA contact for projects of responsibility. + Accountable for… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …approaches. + Ensure training content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance & Risk Management** + ... cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver… more
- Carrier (Beverly, MA)
- …Regulatory Intelligence & Monitoring** + Interpret and monitor global regulatory requirements (eg, CE/MDR, FDA , ISO standards, environmental/transport ... Affairs Certification (RAC) or equivalent professional certification + Regulatory Knowledge on US: FDA , FCC; EU:...professional certification + Regulatory Knowledge on US: FDA , FCC; EU: MDR, Radio Equipment Directive, Low Voltage,… more
- Abbott (Springfield, MA)
- … requirements. * Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... to customers. * Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends. * Resolves and/or facilitates… more
- J&J Family of Companies (Danvers, MA)
- …sales, and education. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... investigators as defined by study-specific requirements and by the applicable regulatory code. + Maintain open communication and relationships with key site… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent… more