- 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
- Deloitte (Boston, MA)
- …relevant consulting experience. + 4+ years of Life Sciences industry experience in the regulatory affairs function to include: + Regulatory operating model ... and development in a variety of ways, including: + Engagement Management: Lead engagement planning and budgeting; mobilize and manage engagement teams; define… more
- Deloitte (Boston, MA)
- …relevant consulting experience. + 4+ years of Life Sciences industry experience in the regulatory affairs function to include: + Regulatory operating model ... Manager in our AI & Data team, you will lead and deliver small engagements, or components of large,... digital transformations / innovations + Submissions management, labeling, CMC change control and/or LCM processes + Veeva RIM… 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 (Boston, 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
- 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