- Astellas Pharma (Westborough, MA)
- …with local and global stakeholders. **Essential Job Responsibilities:** + Acts as a CMC regulatory lead and/or Deputy for highly complex projects/products ... and/or credibility. **Organizational Context:** Reports to Director or Senior Director, Regulatory Affairs CMC . **Qualifications:** **Required** + BS… more
- Astellas Pharma (Westborough, MA)
- …project or product and the application. **Essential Job Responsibilities:** + Acts as CMC regulatory lead or deputy for complex projects/products, requiring ... Long Term Incentive Plan for eligible positions + Referral bonus program \#LI-TR1 Category Regulatory Affairs CMC Astellas is committed to equality of… more
- Actalent (Boston, MA)
- …are highly preferred. Experience: + At least 5 years of relevant experience in CMC Regulatory Affairs for biologics, including involvement with IND ... CMC strategies to support gene therapy development. Key Responsibilities + Lead global Regulatory CMC strategic guidance and provide tactical support to… more
- Sanofi Group (Bridgewater, NJ)
- …of Manufacturing & Supply and CMC R&D, collaborating closely with other Global Regulatory Affairs (GRA) and local regulatory functions, and with many ... topics with other health authorities including international with local/regional teams + Lead the Regulatory CMC content of meetings with FDA, EMA, supports… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with headquarters in Foster City, California. **About the Role:** The Senior Director, CMC Regulatory Affairs for Biologics is responsible for leading ... product in Gilead's global portfolio of biological products in CMC Regulatory Affairs . This position...+ Lead the execution of these global CMC regulatory plans, including overseeing the submission… more
- Bausch + Lomb (Columbus, OH)
- …advancement of eye health in the future. **Objectives** A member of the global technical CMC team for global regulatory CMC strategy for submissions and ... surveillance and US regulatory licensing. **Responsibilities** + Proactively communicate CMC regulatory strategy, key issues and any other critical topics… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. We are seeking an Advisor/Senior Advisor for Global Regulatory Affairs CMC to be a part of the Lilly Global ... Trial Applications, Market Registrations And Post-Approval Submissions. The Research Scientist in Global Regulatory Affairs - CMC will leverage CMC … more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with ... changing requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …the development plans to support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and other functional areas, including external ... creating hope for all facing illness. The Senior Director, Regulatory Affairs - Clinical (Neuroderm), may be...one or more therapeutic areas, and coordinates strategy with RA project management for assigned regulatory projects.… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …as an Associate Director, Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies ... Business Unit at Takeda. The Global Regulatory Affairs CMC & Device organization is responsible for global device regulatory strategies and activities… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs (Early Development) provides strategic global regulatory ... requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including...e-CTD compliance. + As required, serves as a global regulatory lead on a specific or assigned… more
- Takeda Pharmaceuticals (Boston, MA)
- …Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior ... Director Global Regulatory Affairs CMC . **How you...Director Global Regulatory Affairs CMC . **How you will contribute:** +... CMC experience including experience as an RA CMC product lead with… more
- Actalent (Gaithersburg, MD)
- … strategies for assigned projects, in collaboration with Regional Regulatory Affairs representatives and Regulatory CMC . + Represent company in ... Position Summary: The Director of Regulatory Affairs will spearhead the creation...with functional groups to define contributions to submissions and lead regulatory submission teams for assigned projects.… more
- Danaher Corporation (Raleigh, NC)
- …ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will lead the Regulatory Affairs department and report to the Vice ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...this role, you will have the opportunity to: + Lead regulatory submissions, including pre-market applications, product… more
- Actalent (Boston, MA)
- …Masters, PharmD, or PhD preferred. * Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, ... Key Duties & Accountabilities: * Actively represent Regulatory CMC and provide regulatory...to generate and refine the product development strategy. * Lead preparation of high-quality global clinical trial applications in… more
- Takeda Pharmaceuticals (Boston, MA)
- …team, develop as well as oversee development (including updates) and communication of proactive regulatory CMC strategies to global CMC regulatory teams ... capital and financial decisions. + Provides leadership of GRA CMC Biologics & ATMP regulatory team and...across a very complex matrix environment in GRA with CMC RA project leads and other GRA… more
- West Pharmaceutical Services (Exton, PA)
- …and Post-Approval) and ensure timely execution of project objectives in line with regulatory affairs ( RA ) team's priorities. + Manage the preparation, ... ID: 66487 Date: Sep 12, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **_This position is hybrid in nature. Candidates… more
- Takeda Pharmaceuticals (Boston, MA)
- …in Cambridge, MA with the following requirements: Master's degree in Pharmaceutical Sciences, Regulatory Affairs or related field plus 2 years of related ... experience. Prior experience must include: Knowledge of global regulatory guidelines, and understanding of Good Documentation Practices (GDP), Good Manufacturing… more
- AbbVie (Cambridge, MA)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is responsible for the ... years' experience in pharmaceutical regulatory activities; preferably with experience as lead regulatory product strategist in at least 2 regions in addition… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …providing oversight for device and drug-device combination work outsourced by the Global Regulatory Affairs CMC Device and Drug-Device Combinations to ... demonstrating Takeda leadership behaviors + Serves as primary Global Regulatory Affairs CMC Device and...project team and properly manage tasks and work expectations, lead , be influential and effective, collaborate with GRA Liaisons,… more