- Orchard Therapeutics (Boston, MA)
- …business priorities. This role represents a unique opportunity to contribute to Regulatory CMC activities supporting maintenance and development of Orchard's ... products in clinical development: . Participate in definition and implementation of Regulatory CMC strategy for assigned program(s). . Collaborate with Technical… more
- Fresenius Medical Center (Waltham, MA)
- …to comply with regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support ... The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Deloitte (Boston, MA)
- …of health Recruiting for this role ends 6/30/2025 Work You'll Do As a Manager you will lead and deliver engagements, or components of large, complex engagements. ... experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and… more
- Sumitomo Pharma (Boston, MA)
- …clinical supplies on multiple clinical programs. In addition, working closely with CMC , Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA ... motivated, and experienced individual for the position of **Senior Manager , Clinical Supply Chain** . The Senior Manager...and/or local regulations. + Collaborate closely with Clinical Operations, CMC , Regulatory Affairs, QA, and PDM to… more
- AbbVie (Worcester, MA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager of Program Management will lead the Manufacturing Project Management ... and our External Contract Manufacturing business partners. The Senior Manager provides project management leadership to ensure successful technical transfers… more
- Takeda Pharmaceuticals (Boston, MA)
- …integral part of the Pharmaceutical Sciences Sustainability and Technology (PSST) Sustainable CMC & Innovation team within PharmSci, In Silico First Program and ... Strategy Manager is crucial to operational efficiency & technical direction...and driving new operational methodologies, while adhering to evolving regulatory compliance requirements. Moreover, this role establishes key metrics… more
- Sumitomo Pharma (Boston, MA)
- …**Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, ... closely with program management, clinical development, PV, Biostat/Data Management, CMC , Biomarker/Translational Research, preclinical DMPK, etc to formulate clinical… more
- Rhythm Pharmaceuticals (Boston, MA)
- …review, and approval of standard procedures. + Author and review regulatory CMC submissions including analytical procedures, method validations, reference ... our tenacity to overcome barriers, together. Opportunity Overview The Quality Control Manager is responsible for oversight of testing performed at Rhythm's contract… more
- WuXi AppTec (Natick, MA)
- …oligo and peptide discovery business along with cultivating these relationships into CMC for IND enable studies with our manufacturing (CDMO) business. The candidate ... and seminars. + Maintains knowledge of industry trends, funding, regulatory influence, mergers and acquisitions, in-out licensing of products/technologies,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… more
- Takeda Pharmaceuticals (Boston, MA)
- …versatile and strong enterprise leaders + be committed to simultaneously driving regulatory approval as well as product launch and global patient access + ... the GPL on the sub-team objectives. + Accountable with the Global Program Manager for operating budgets within the global program; leads budget setting in… more