- Leica Biosystems (Boston, MA)
- …development and registration activities for the respective medical productsDevelop and manage regulatory submissions (eg, 510(k), PMA, EU Technical Files, STED), ... clinical trials, including IDE approvals and EU Performance Study Application submissions .Experience with developing and documenting regulatory strategies in… more
- Kura Oncology (Boston, MA)
- … risks, considerations, and strategies for program(s). Ensure activities and regulatory submissions are compliant with relevant laws, regulations, and ... regulatory documents and developing responses to Agency queries; manage submissions in coordination with regulatory operations. Lead and/or assist in… more
- EPM Scientific (Bridgewater, MA)
- …and life-cycle management teams. Ensure timely and accurate preparation of regulatory submissions and responses to health authorities. Collaborate with ... A leading global pharmaceutical company is seeking an Associate Director of Regulatory Affairs to support regulatory development and post-approval compliance for… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …as the global clinical pharmacology lead on PDT projects and contribute to regulatory submissions and interactions. This role requires a strong strategic ... and/or oversee pharmacometrics projects to support the program progression and regulatory submissions . The relevant pharmacometrics projects may include and… more
- Alkermes (Waltham, MA)
- …clinical program design, trial protocols, analysis plans, study reports and regulatory submissions Conducting and overseeing pharmacokinetic (NCA) analysis, ... working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations. Hands on modeling experience is desirable. Essential… more
- Ardelyx (Waltham, MA)
- …GLP and GCP study protocols and reports, clinical study reports, external publications, regulatory submissions , etc. Oversee the PV audit program and PV ... guidance with a strong emphasis on compliance and direct experience with regulatory submissions Must have direct experience with hosting, leading and managing US… more
- Eli Lilly and Company (Boston, MA)
- …/late- phase clinical program. Extensive preparation of control strategy and regulatory submissions supporting clinical development. Experience with mentoring ... and coaching senior level scientists and engineers. Skills and Preferences Comprehensive knowledge and deep understanding of (1) traditional and new modalities of parenteral drug product development (2) parenteral manufacturing and aseptic technologies, and… more
- Nanobiosym (Cambridge, MA)
- …matters, including licensing agreements, collaborations, M&A due diligence, and regulatory submissions . Dispute Resolution: Support IP litigation, opposition ... strategies. Prior in-house legal experience in a biotech or pharmaceutical company. Familiarity with regulatory frameworks (eg, FDA, EMA) as they relate to IP. more
- Katalyst HealthCares and Life Sciences (Cambridge, MA)
- …issues to troubleshoot for resolution for business continuity. Experience in development of Regulatory CMC strategy in support of submissions of clinical trial ... and standards are properly and timely implemented. Provide support to Regulatory CMC managers in developing strategy for development projects, including assigned… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- …follow-up of submissions under review. Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM ... for submissions . Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation. Reviews… more
