- Sumitomo Pharma (Boston, MA)
- …and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or ... and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of… more
- Catalent Pharma Solutions (Chelsea, MA)
- …testing is conducted in line with the appropriate expectations, guidelines and/or regulatory test standards. **This is a full-time on-site salaried position: Monday ... and internal sources (ie health authorities, clients, self-inspections) + Understands regulatory requirements and their application as suitably scoped to support… more
- AbbVie (Worcester, MA)
- …the qualification and validation of analytical methods in accordance with ICH, FDA , and USP guidelines, ensuring methods are suitable for late-phase development and ... regulatory submissions. + Experience using automation to standardize high-throughput...Familiarity with statistical tools for data analysis, Empower and regulatory guidelines. + Experience collaborating with the process development,… more
- Parexel (Newton, MA)
- …review, and approve high-quality country-specific and site-specific documents, essential regulatory documents, and updated or amended regulatory documentation. ... for Harmonisation of Technical Requirements (ICH), Food and Drug Administration ( FDA ), country clinical research law and guidelines, and Good Documentation… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …helps to ensure compliance of the clinical research enterprise with all related regulatory policies and guidelines, including federal, state, local, as well as the ... as outlined in the monitoring plan and in compliance with all related regulatory standards. Monitoring will be performed through a combination of remote data review… more
- Sumitomo Pharma (Cambridge, MA)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- Norstella (Boston, MA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- Sanofi Group (Cambridge, MA)
- …a highly visible and priority launch asset for Sanofi Specialty Care. Since its FDA approval in 2023, ALTUVIIIO has been steadily gaining market share and represents ... lead initiatives: Patient Services, Market Access, Sales force, Medical, Legal, Regulatory , Business Ops and Multiple agencies + Detail-oriented self-starter capable… more
- Wolters Kluwer (Waltham, MA)
- …success managing product line projects, including risk mitigation, regulatory awareness, translating customer needs into business requirements, stakeholder ... and tracking success metrics. * Leverage knowledge of US healthcare government and regulatory published drug information and policy data sources (CMS, FDA , etc.)… more
- Deloitte (Boston, MA)
- …technologies like GenAI, AI/ML, and automation for analytical methods, manufacturing, regulatory and/or QA/QC + Implementation of regulatory authoring tool(s) ... ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in.../EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years… more