- Regeneron Pharmaceuticals (Troy, NY)
- …are seeking a highly motivated and experienced regulatory professional responsible for overseeing CMC aspects of global submissions . This position would ... Regeneron is currently looking for a Staff CMC Regulatory Sciences Specialist for...+ Experience in managing non-US/EU markets global submissions + Strong knowledge of CMC regulatory… more
- Bristol Myers Squibb (Summit, NJ)
- … regulatory guidelines and experience. + Prepare or oversee preparation of CMC submissions while ensuring thoroughness, completeness, and timeliness. + Review ... of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with... submissions from CMC Leads for clarity of… more
- Takeda Pharmaceuticals (Boston, MA)
- …having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred. ... and staff . Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by applying interpersonal skills and… more
- Eurofins (Indianapolis, IN)
- …are not limited to: + Leads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions + Takes a proactive ... strategies and submission content. + Makes technical decisions on CMC regulatory issues impacting product submissions across...but Optional: + Three or more years of direct global regulatory CMC experience, or equivalent experience… more
- J&J Family of Companies (Horsham, PA)
- …Health Authorities under supervision of a senior member of the department. + Reviews CMC regulatory dossiers for global submissions throughout the product ... development and commercialization. This person is responsible for developing global CMC regulatory strategies. The primary responsibility...a senior member of the CMC RA staff . + Strong knowledge of global HA… more
- Bristol Myers Squibb (Summit, NJ)
- …Cell Therapy group in the preparation of CMC Regulatory Strategy and submissions and interactions with Global Health Authorities. + Attend and participate in ... be based in Summit, NJ and will assist the Regulatory- CMC Cell Therapy team with projects to support department...with daily check-ins and to work cooperatively with senior staff providing key assistance on complex assignment + Computer… more
- J&J Family of Companies (Malvern, PA)
- …budgets and timelines for their program(s). In addition, the role will oversee CMC regulatory submissions and responses to deliver clinical and launch drug ... efficient delivery on projects. The position reports to VP, Global Head of CMC Portfolio Strategy and...interfaces. Ensures new process and training are provided to staff to understand new technologies impacting the portfolio. +… more
- J&J Family of Companies (Malvern, PA)
- …timelines for the antibody conjugate portfolio. In addition, the role will oversee CMC regulatory submissions and responses to deliver clinical and launch drug ... efficient delivery on projects. The position reports to VP, Global Head of CMC Portfolio Strategy and...mentorship to scientific leaders for products in development. Ensures staff are properly trained for their role as CMCL.… more
- AbbVie (North Chicago, IL)
- …of experience. + Proven track record of developing and implementing successful global CMC control strategies. Experience interfacing with regulatory agencies ... function's capabilities based on emerging modalities and technologies to support future pipeline submissions . + Collaborate with and advise CMC project teams in… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …organizational goals, and current policies + Provide and drive strategic and operational global CMC regulatory direction and documentation for portfolio of CGT ... Leads the Chemistry, Manufacturing, and Controls ( CMC ) non-antibody team for cell and gene therapy...and/or biologics. Perform final review and approval for all global submissions for the portfolio to ensure… more
- Sanofi Group (Waltham, MA)
- …for COVID. + Align research activities with clinical trial expectations such as IND submissions , support for CMC , and toxicology testing, as needed. + Lead ... **About the Job** We are an innovative global healthcare company that helps the world stay...are aligned with clinical trial expectations, such as IND submissions , and establishing Co- CMC and Co-clinical development… more
- Bristol Myers Squibb (Summit, NJ)
- …team to deliver Regulatory documents and / or assignments/deliverables in support of CMC submissions + Attend and participate in various Regulatory and matrix ... team with projects to support department goals and objectives. The GRS/GRS- CMC departments support global clinical trial applications, product registration,… more
- Sumitomo Pharma (Columbus, OH)
- …+ Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions + May be responsible for creating and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...advertising of assigned products. This position may train/mentor junior staff . This position works with a high level of… more
- Lilly (Indianapolis, IN)
- …and regulatory submissions . + Possess deep understanding of the external global regulatory climate and emerging requirements; ability to address key CMC ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Bristol Myers Squibb (Summit, NJ)
- …Engineer, Product Management** **Location:** **Summit, NJ** Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, ... plays a critical role in investigations, technology transfers, process validation, CMC life cycle management, technical oversight of external and internal… more
- Bristol Myers Squibb (Seattle, WA)
- …direction for continuous improvement. + Contribute to, review and approve regulatory CMC submissions to ensure their quality and technical content ... **Summary:** The Executive Director, Drug Product Process Development is accountable for global network of cell therapy DP process development. This role is… more
- AbbVie (North Chicago, IL)
- …. AbbVie Analytical Research & Development (Analytical R&D) is a global analytical sciences organization responsible for all CMC analytical ... Careers in AbbVie Analytical R&D provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product… more
- Bausch Health (Petaluma, CA)
- Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, ... impact. DESCRIPTION OF JOB: Creates and executes extensive analytical and CMC development plans for pharmaceutical active ingredients, excipients, oral and topical… more
- Novo Nordisk (Lexington, MA)
- …appropriate, in support of the development objectives for the and assist Regulatory Strategy staff in the compilation of submissions and in the responses to ... About the Department Our East Coast Global Development Hub brings together the best minds...the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Quality by Design (AQbD) + Experience in reviewing and approving analytical-related CMC sections of BLA/MAA regulatory submissions . Knowledgeable in European, ... for Bioanalytics for late stage Biologics programs + Manage staff with accountability for performance and talent development +...the department and influencing scientific and process improvement in global AD. + Strong knowledge of ICH and other… more