- Abbott (Burlington, MA)
- …(EMS), and other regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company ... regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating… more
- Sanofi Group (Cambridge, MA)
- …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... compliance with all corporate and industry policies and legal and regulatory requirements, for all medical affairs activities + Ensure promotional/non-promotional… more
- Sumitomo Pharma (Boston, MA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... Provide clinical and medical expertise across all stages of drug development, from preclinical transition to post-marketing. + Stay... Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions,… more
- Cognizant (Boston, MA)
- …and Computer Software Assurance (CSA) processes Knowledge on ALM Test management tool Regulatory Knowledge: Strong understanding of FDA , EMA, GxP, and 21 CFR ... Responsibilities_** Develop and implement comprehensive Validation and Test strategies aligned with regulatory requirements such as FDA , EMA, and GxP standards,… more
- Staples (Framingham, MA)
- …to positively influence associate and customer safety, as well as minimize regulatory risks and exposures. This role will enhance operating efficiencies through ... to standardize, harmonize and support the execution of safety and regulatory compliance programs including: . Workplace Safety, Hazardous Substance management… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Engineer with the following duties: Write Validation documents per Food Drug Administration ( FDA )/Company guidelines; draft Specification documents and ... (RTM) and Validation Summary Reports (VSR) etc. per Food Drug Administration ( FDA ) and other US pharmaceutical...observations and agency questions; author and review sections of regulatory filings and annual product quality reviews.; up to… more
- IQVIA (Boston, MA)
- …to make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. ... and identifying new business opportunities. + Provide due diligence scientific, medical, regulatory , and drug development expertise and activities for IQVIA or… more
- Charles River Laboratories (Shrewsbury, MA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will...improvement in site operations and ensure successful audits by regulatory agencies. Duties also include delegated activities as per… more
- Charles River Laboratories (Wilmington, MA)
- …and drug development. Prior direct experience in interacting with regulatory agencies is preferable. Prior experience in program management and/or Pharm/Tox ... experienced professional with expertise in establishing effective scientific and regulatory strategies to advance new medicines through the various...of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five… more
- Catalent Pharma Solutions (Chelsea, MA)
- …quality of final products. **EDUCATION AND** **EXPERIENCE** : Requires a Bachelor's degree in Drug Regulatory Affairs and 4 years of experience in job offered or ... Perform various quality assurance checks during all manufacturing processes; Assess regulatory and quality risks in manufacturing activities and processes according… more