- 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
- Lilly (Indianapolis, IN)
- …Applications, Market Registrations And Post-Approval Submissions . The Research Scientist in Global Regulatory Affairs - CMC will leverage CMC technical ... technical expertise, to strengthen submission or minimize risk. * Reviews and approves CMC documents for global regulatory submissions , including … 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 (Columbus, OH)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- … CMC Pharmaceuticals Development Portfolio Lead where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC ... GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM… 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
- Takeda Pharmaceuticals (Boston, MA)
- …with line management + Supports and/ or leads assigned device-related aspects of global regulatory submissions (eg, Core Dossiers, INDs, CTAs, BLAs, MAAs, ... relations with key internal and external stakeholders. + Develops CMC Device & Combination product staff on...BLA, MAA, NDA, 510(k), Notified Body Opinions, Technical File submissions , global post approval submissions ,… more
- Regeneron Pharmaceuticals (Troy, 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
- Actalent (Boston, MA)
- … submissions o Plan kick-off meetings and comment resolution meetings for major submissions and support Reg Dev/ CMC leads in content and action plans o ... Manage submission-related activities o Working with Reg Dev and CMC leads, create content plans and submission timeline for...for selected regulatory vendor(s) * Plan and execute regulatory submissions with the vendor in a timely manner, including… 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 Global Regulatory Sciences - CMC Cell Therapy...with daily check-ins and to work cooperatively with senior staff providing key assistance on complex assignments + Computer… more
- Lilly (Indianapolis, IN)
- …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 ... product, process validation, process controls, compliance, continuous process optimization, CMC regulatory support, manufacturing data analysis and process data… 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
- Merck (West Point, PA)
- **Job Description** Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. The ... and an inspiring mission to achieve new milestones in global healthcare. Our company is on a quest for...key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure development of robust… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …The role will also be responsible for review and authoring of key CMC submissions , along with setting relevant standards and creating /maintaining associated ... until the completion of process performance qualification and subsequent CMC filing activities. + Development, characterization, optimization and troubleshooting… more
- Astellas Pharma (Westborough, MA)
- …of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of ... not limited to: Manufacturing, Process Development, Quality Assurance, R&D, Regulatory, CMC teams, Facilities, Validation, Supply Chain, Quality Control, and various… 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
- 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
- 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
- Merck (Rahway, NJ)
- **Job Description** Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our ... integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our company is seeking a highly motivated candidate for the… more