- Actalent (Boston, MA)
- …in relevant regulatory submission management * In-depth knowledge of regulatory submissions , particularly eCTD structure and Modules * A thorough working ... CMC leads, create content plans and submission timeline for regulatory submissions o Plan kick-off meetings and...staff in the application of various standards templates, document management practices, eCTD submissions review, and other… more
- Medtronic (Woburn, MA)
- …innovation in a more connected, compassionate world. **A Day in the Life** The Regulatory Affairs Program Manager will lead the strategic planning and execution ... of regulatory submissions and compliance initiatives within the...+ Bachelors degree with 5+ years of medical device regulatory affairs experience OR + An advanced… more
- Fresenius Medical Center (Waltham, MA)
- …activities within Regulatory Affairs for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals and ... A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of...the regulatory document management system, regulatory information system, and electronic submissions . +… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will define, develop and lead ... regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with… more
- Philips (Cambridge, MA)
- …plan, and outline proposal for balancing the project risk to project teams and Regulatory Affairs Management . + Lead business critical new product ... The Principal Regulatory Affairs Specialist will play a...NMPA, De Novo, Technical Documentation, and EU MDR /International regulatory submissions /registrations required. + You have proven… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …compliance and timely product clearances and/or approvals. + Represent regulatory affairs on project/product teams, risk management , and all design review ... meetings. + Working with department management provides regulatory guidance and guidance on...Affairs Certification preferred + Experience with medical device regulatory submissions (510(k) or PMA preferred +… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …compliance and timely product clearances and/or approvals. + Represent regulatory affairs on project/product teams, risk management , and all design review ... meetings. + Working with department management provides regulatory guidance and guidance on...Affairs Certification preferred + Experience with medical device regulatory submissions (510(k) or PMA preferred +… more
- J&J Family of Companies (Boston, MA)
- …regulatory strategies as new data become available. + Escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory ... Associate Director, CMC Regulatory Affairs - 2406221330W **Description** Johnson...regulatory requirements and expectations. Communicates critical issues to Management **Sphere of Authority** + Ensures the CMC development… more
- Dana-Farber Cancer Institute (Boston, MA)
- The Regulatory Affairs Specialist (RAS) positions provides advanced expertise and regulatory support to 600+ investigators and research staff members at ... protocol and monitoring processes prior to IRB review. The Regulatory Affairs Specialist (RAS) positions are critical... regulatory -associated processes, including but not limited to e- Regulatory Management and the IND and IDE… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... and partners, in the preparation, review, and completion of documents for regulatory submissions . + Successfully plan, prioritize, supervise and/or conduct… more
- Takeda Pharmaceuticals (Boston, MA)
- …members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management and Strategic Planning (RPM&SP) head. Identify and propose ... Management ), preferably with 4 Yrs. In Global Regulatory Affairs + Experience working on late...colleagues. + Significant experience in global drug development regulations, regulatory submissions , lifecycle management , compliance,… more
- Takeda Pharmaceuticals (Boston, MA)
- …within their responsibilities. + Serves as the lead interface between PDT global regulatory affairs , global subject matter experts, international LOCs, EU & ... regulatory subteam (GRT) and, cross-functional subteams and working group to execute regulatory submissions . Assists in the creation and submission of high… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with ... related experience. + Experience in reviewing, authoring, or managing components of regulatory submissions . + Expert knowledge of drug development process and… more
- Dana-Farber Cancer Institute (Boston, MA)
- …milestones. + Assists in the management and training of the regulatory documentation process regarding submissions that may include the preparation of ... The AROM is directly responsible for closely managing all regulatory submissions reaching the activation phase to...active and close out phases. + Proficient knowledge of regulatory affairs , research ethics and the responsible… more
- Takeda Pharmaceuticals (Boston, MA)
- …on strategy, define executable timelines, and agree upon content for nonclinical regulatory submissions . + Represents NRWS on cross-functional project teams to ... plan and communicate about nonclinical regulatory submissions . + Understands and applies the...regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage.… more
- Takeda Pharmaceuticals (Boston, MA)
- …of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and Global ... and execute internal change to continuously improve our products, systems and submissions + Collaborating with Regulatory policy and Intelligence team as… more
- Sanofi Group (Cambridge, MA)
- …pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience or Advanced degree (PharmD, PhD, MD ... **Job Title:** Regulatory Strategist **Primary Location** : Cambridge, MA **About...products in development as well as for life cycle management of products + Participates in the development and… more
- Sanofi Group (Cambridge, MA)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global), in early and ... **Job title: Regulatory Strategist** + **Location:** Cambridge, MA or Bridgewater,...products in development as well as for life cycle management of products. + May serve as a regional/local… more
- Actalent (Boston, MA)
- …or PhD preferred. + Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, DSURs and Agency ... to agency questions, and maintenance activities. + Coordinate and drive regulatory CMC submissions , including assembling necessary cross functional teams… more
- Capgemini (Boston, MA)
- …** Regulatory Information Management :** o Manage the lifecycle of regulatory submissions , including the preparation, tracking, and filing of documents in ... Veeva Vault RIM platform. The ideal candidate will have a strong background in regulatory affairs , experience with Veeva solutions, and a deep understanding of… more