- Integra LifeSciences (Braintree, MA)
- …are challenging what's possible and making headway to help improve outcomes. The Regulatory Affairs Specialist is an intermediate level role responsible for ... regulations in the US, EU, Canada and globally. The Regulatory Affairs Specialist is responsible for providing...strategies, and revise technical documentation for existing and new regulatory submissions . + Aid Supervisor in the… 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
- Teleflex (Chelmsford, MA)
- …and procedures and communicate to internal stakeholders. * Brings Regulatory Affairs questions/issues to the attention of RA management . * Comply with ... Sr. Regulatory Affairs Specialist **Date:** Oct 23,...will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to… 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
- 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 (Lexington, MA)
- …ensuring timely communication with line management . + Leads assigned global regulatory submissions (eg, Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, ... across the business. **How you will contribute:** + Develops, executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy.… more
- Actalent (Cambridge, MA)
- … vendors. The ideal candidate will have a strong background in regulatory affairs and experience with IND and BLA submissions . Responsibilities + Work with ... Job Title: Regulatory Submissions Specialist Job Description We...communication skills. + Proficiency with publishing tools. + Timeline management experience. + Experience with early and late-stage global… 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
- Merck (Boston, MA)
- … submissions , including IND, NDA, BLA, and MAA applications. + Ensure that regulatory submissions meet the requirements of FDA, EMA, and other health ... + Stay updated on emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as a key member of… 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