- Amgen (New Albany, OH)
- The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for ... manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC experience + Ability to develop solutions to… more
- Takeda Pharmaceuticals (Boston, MA)
- …Americas, Inc. for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager , CMC Regulatory Compliance (GRA, CMC ) **POSITION ... DESCRIPTION:** Takeda Development Center Americas, Inc. is seeking a Manager , CMC Regulatory Compliance (GRA,...and local operational activities within Global Regulatory Affairs - Chemistry, Manufacturing and Controls (GRA CMC… more
- System One (San Rafael, CA)
- Job Title: Senior Manager - CMC Regulatory Location: Hybrid - Local to San Rafael, CA Type: Contract Description: As a Senior Manager in the ... responsible/accountable for: RESPONSIBILITIES Planning, preparation and submission of global regulatory CMC -related content pertaining to clinical trial… more
- Actalent (Waltham, MA)
- …to clinical pipeline + Proactively partners with Process and Analytical Science, Regulatory Affairs , Quality, Manufacturing and Supply Chain teams to ensure ... Description: We are looking for an experienced CMC operations manager to join our...as well as program/project management required. + Understanding of CMC development, regulatory CMC requirements,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …The purpose of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Fresenius Medical Center (Knoxville, TN)
- …+ Experience in project management respectively change control process + Experience in regulatory affairs or in a quality environment, ideally in a ... to comply with regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support… more
- West Pharmaceutical Services (Exton, PA)
- …ID: 66496 Date: Mar 5, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **_This position is hybrid(3 days onsite) in ... Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West's global...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary:** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC ... - 8 years of pharmaceutical industry experience with 2+ years of direct or related CMC regulatory experience preferred + Ability to travel up to 5% _Daiichi… more
- Gilead Sciences, Inc. (Foster City, CA)
- …/pharmaceutical CMC development and commercial teams, GMP environment and regulatory affairs + Prior experience in project management required; PMP ... planning and execution of multiple small molecules and/or biologics CMC programs. The Sr. Project Manager will...candidate will bring an understanding of drug development and regulatory processes, and the ability to assess and drive… more
- Actalent (Omaha, NE)
- …to team members on systems, policies, procedures, and core processes. + Support Regulatory Affairs , including compiling CMC documentation for FDA ... Job Title: Quality Systems Manager Job Description The Quality Systems Manager...and ensure resolution in accordance with company guidelines and regulatory requirements. + Monitor risk-management procedures, maintain problem logs,… more
- Vera Therapeutics (Brisbane, CA)
- …and inventory management of clinical supplies. Working with third-party packaging suppliers, Regulatory Affairs , Quality Assurance, CMC , and the Clinical ... Title: Clinical Supply Chain Manager Location: Brisbane, California About Us: Vera Therapeutics...as part of a team with other members of CMC to ensure on-time delivery of IMP and adequate… more
- Insight Global (New York, NY)
- …In this role, you will lead our clients effort in supporting Quality, Regulatory , Clinical, Medical Affairs , and Biometrics teams. This role will focus ... Insight Global is seeking a Senior IT GxP Program Manager for one of our healthcare clients that is...Implementation: o Design and implement solutions to support Quality, Regulatory , Clinical, Medical Affairs , and Biometrics teams.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …(Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA RD functional areas, Regulatory Affairs - CMC , Pharmacovigilance, Medical Affairs ... as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits. + Drug… more