- BeOne Medicines (San Mateo, CA)
- …taken when recalls or product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and ... regulatory strategies as well as authoring CTD CMC sections for the assigned project to...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Abeona (Cleveland, OH)
- Position Overview We are seeking a highly skilled and driven Senior Manager of Project Management to lead and drive strategic execution of multiple ... commercialization and capacity expansion objectives. + Collaborate with Clinical Operations, Regulatory , Medical Affairs, CMC , Biometrics, and other functional… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …and pivotal clinical studies, through to market application approvals (BLA, NDA) in partnership with CMC Team Project Manager . + Accountable for CMC ... Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC , Commercial Manufacturing, etc.) to define and… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- BeOne Medicines (Emeryville, CA)
- …cost-effective production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new ... **_General Description:_** Sr. Manager /Associate Director, Supply Chain CMO Management & PM...a scientific field. Minimum 10 years' experience within biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements **Computer… more
- ThermoFisher Scientific (Wilmington, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... depend on - now and in the future. Our Project Delivery colleagues within our PPD(R) clinical research services...global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC… more
- ThermoFisher Scientific (Wilmington, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more
- AbbVie (North Chicago, IL)
- …Chemistry, Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC - Regulatory . Responsibilities: + Manager a small team (3 ... R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.… more
- J&J Family of Companies (Raritan, NJ)
- …initiatives in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, Regulatory Affairs, CMC Regulatory Affairs, Product Artwork, and ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to ... the care of patients with life-threatening diseases. The **Sr. Clinical Supply Manager ** is a leader that inspires teams while providing expertise for Gilead's… more