- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …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
- Eurofins US Network (Lancaster, PA)
- …substances and products. **Job Description** **Role Overview** The GMP Testing Project Manager is responsible for planning, coordinating, and overseeing ... strategies. + Ensure all deliverables meet client expectations and regulatory requirements. + Prepare and present project ...biologics. + Experience in GMP lab operations, especially in CMC testing. + Proven ability to manage complex projects… more
- Kelly Services (Malvern, PA)
- …other cross-functional departments + Participate in and/or lead cross-functional meetings with CMC and project team representatives and stakeholders + Lead ... ** Project Coordinator** Kelly Services is currently seeking a...of Kelly Services, Inc., is currently seeking a Content Manager for a 12 month + engagement at one… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …not limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible for the development of ... the regulatory requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category in accordance with FDA… more
- Takeda Pharmaceuticals (Lexington, MA)
- …or more products and provide strong technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. ... and timely decision-making. + Represent Biologics Product Sciences on cross-functional CMC and project teams and collaborate closely with Pharmaceutical… more
- Boehringer Ingelheim (Duluth, GA)
- …stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with RA project team members, helps drives ... initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving...and responsible for supporting RA leader by reflecting the regulatory submission timing needed for project program.… more
- ThermoFisher Scientific (Greenville, 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
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …You will also represent the drug product process science perspective in regulatory CMC interactions, translating process understanding into clear and defensible ... + Local Technical Services organizations + Global Quality and Regulatory CMC teams + Ensure process knowledge...and/or parenterals). + Demonstrated success as an SME and project leader in a matrix environment, influencing technical decisions… more
- Bristol Myers Squibb (Devens, MA)
- …to ensure product quality, compliance and supply. + Author, review and approve regulatory CMC submission sections. + Drive continuous improvement initiatives to ... influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes. + Knowledge of CMC regulatory , drug substance & drug product manufacturing, and… more
- BeOne Medicines (Emeryville, CA)
- …commercial negotiations, defining responsibilities between BeiGene and the CMO. Act as project manager of the contract negotiation with close partnership with ... **General Description:** The Senior Procurement Manager of CMO Category is responsible for establishing,...with contract manufacturers (CMOs) worldwide, Commercial Supply Chain, CMO Project Managers, Alliance Managers, Quality and CMC … more