- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. ** Head of CMC Regulatory Affairs - Small Molecules** **KEY RESPONSIBILITIES** ... The Head of CMC Regulatory Affairs - Small...CMC regulatory strategies to enable life-cycle product/process development strategy while maintaining global licensure and right to operate… more
- Merck (Rahway, NJ)
- …for managing a team of CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery of high-quality CMC submissions ... professionals and ensuring a high standard of rigor in CMC regulatory strategy . Their duties also encompass...environment with potential strategic impact working closely with the Head of CMC Regulatory Policy. + Performs… more
- WuXi AppTec (Cranbury, NJ)
- …and technology platform company serving the life sciences industry, with global operations across Asia, North America, and Europe. As a premier Contract Research, ... and high-quality solutions for integrated chemical, manufacturing and controls ( CMC ) from preclinical to commercial uses. WuXi TIDES is...chain under one roof. We are looking for a Head of Marketing and Communications who'll lead WuXi STA… more
- CSL Behring (King Of Prussia, PA)
- …CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to ... and often rare conditions. Could you be our new Head of Global Pathogen Safety Scientific Liaison? This position...awareness within CSL and creating GPS external scientific advocacy strategy following GPS strategy and CSL goals.… more
- Bristol Myers Squibb (Summit, NJ)
- …Review/author technical sections of major regulatory documents and contribute to the overall CMC strategy of the current vector technologies and future gene ... careers.bms.com/working-with-us . The Executive Director of Cell Therapy Vector Operations will report to the Vice President of CTTO....for both the Vector and CAR-T drug product. The head is expected to hire, develop and grow strong… more
- CSL Behring (King Of Prussia, PA)
- …MA, or Boca Raton office. It is a Hybrid role. You will report to the VP, Head of GRA CMC . You will provide strategic leadership and oversight in building global ... Authorities, Industry Associations) and company partners to shape regulatory CMC requirements. You will lead and direct strategy...our mission. o As a member of the GRA CMC Leadership Team, support the Head GRA… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. **JOB DESCRIPTION** + ... flexibility the incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout the product… more
- Novo Nordisk (Boulder, CO)
- About the Department The Boulder Site is home to the specialized technical operations / CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy ... in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations...and development teams. Relationships This position reports to the Head of IP and Legal, US R&D. The role… more
- Bristol Myers Squibb (Warren, NJ)
- …and technical operations . To achieve these objectives, the Attribute Sciences head will be expected to behave as a servant-leader that seeks to develop, ... than here at BMS with our Cell Therapy team. **Position Summary:** As the Head of the Cell Therapy Attribute Sciences group, the energetic and motivated Sr. Director… more
- Teva Pharmaceuticals (West Chester, PA)
- …the clinical development plan and will provide leadership for assigned asset strategy , working closely with other functional areas such as commercial, regulatory, ... pharmacovigilance, CMC , and pre-clinical development in this regard. The Director...the cross-functional clinical development team + Supports Global Clinical Operations in clinical trial initiation, resource planning, study implementation… more
- Sanofi Group (Swiftwater, PA)
- …within budget targets + Collaborate with Head of Strategic Alliances and Head of Global Clinical immunology to ensure strategy for assay development, ... support for regulatory communications and filings, as well as define the strategy for clinical endpoints and develop serology, mucosal/ cell mediated immunogenicity,… more
- Randstad US (Cambridge, MA)
- …As part of the GMSO Program Management team, you will report to the Strategy & Operations Lead, Gastroenterology + Leads the program and project planning ... business objectives. + Addresses and resolves project challenges, keeping Unit Head / Lead MPM informed of critical considerations (eg, resources, performance… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …development and execution of the post-approval regulatory strategy , post-marketing commitments,post-marketing development and maintenance,regulatory operations ... Canada. In addition, the Senior Director, Commercial Regulatory Affairs, in collaboration with Head , Regulatory Affairs and CMC -RA, will review and assess all… more