- 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
- Bausch + Lomb (Boston, MA)
- …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
- 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
- Randstad US (Cambridge, MA)
- …matrixed, global product team-oriented environment and ensures close collaboration within the Global Regulatory Affairs CMC & Device organization and with ... submission approach globally, regionally and locally The Contractor, Global Regulatory Affairs CMC , PDT BU... requirements and demonstrated ability to function as the lead interface with FDA. + Demonstrated ability to develop… 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
- Takeda Pharmaceuticals (Boston, MA)
- …to senior management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive ... Director and Head, CMC Regulatory Affairs - Pharmaceuticals....in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders… 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 (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
- 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)
- …Establish collaboration with Takeda teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives on drug-device ... filings through clinical development and commercial product lifecycle + Lead regulatory strategy, briefing book authoring and...across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA… more
- Takeda Pharmaceuticals (Lexington, MA)
- …with colleagues in Pharmaceutical Sciences, Supply Chain Operations, Quality Assurance and CMC - regulatory Affairs , while serving as an important point ... in development and/or manufacturing. + Experience in the GMP environment, and regulatory affairs . + Experience managing technical capabilities in a global… more
- Bristol Myers Squibb (Devens, MA)
- …Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs , and other Cell Therapy Development ... QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions. + Supports the overall product quality… more
- Takeda Pharmaceuticals (Boston, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced understanding in DMPK, ... governance and development teams while providing strategy and accountability for CMC deliverables. + Lead training of early-stage functional PS-Leads… more
- Sanofi Group (Cambridge, MA)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their ... management of products. + May serve as a regional/local regulatory lead and point of contact with...pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global), in… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs + Has knowledge of fundamental ... high functioning team of senior PS program leaders that lead a significant portion of the R&D portfolio that...understanding in Clinical Sciences, Regulatory CMC , DMPK, Pharmacology and Toxicology +… more
- Sanofi Group (Cambridge, MA)
- …development experts, statisticians, clinical operations personnel, medical writers, safety experts, regulatory affairs , medical affairs and external key ... is to collaborate with the physicians, assisting GPH, Clinical lead and CRDs in activities around the compound, MA...preparation of supportive documents for AdBoards and meetings with Regulatory Affairs + Literature review update related… more