- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences ... (Preferably) 4 + years of experience with at least 2 + years within CMC Development in the pharmaceutical/biopharmaceutical industry preferred- 4 or More Years… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and approach to engage with trade associations, regulators and other relevant industry stakeholders on key regulatory topics both globally and regionally, ... biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory - CMC function and corporate affairs as needed. In the short… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or New Modality) team.- Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Insmed Incorporated (Bridgewater, NJ)
- …areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards.Provide scientific guidance on study ... discipline. DABT/DACVP certification preferred.Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Insmed Incorporated (Bridgewater, NJ)
- …areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards.Provide scientific guidance on study ... discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Merck & Co. (North Wales, PA)
- …that facilities/processes are compliant and support approval of new modality regulatory filings.our Technical CMC teams for end-to-end Quality oversight/support ... GMP and Regulatory compliance.Stay ahead of current GMP requirements and industry trends as described in worldwide regulations and industry standards, and… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC ...accredited college or university. + 10 years of pharmaceutical industry experience + 6 years of Regulatory ... and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to manage and help develop … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... leadership and develop CMC regulatory strategy for global vaccine programs...to teams and line management. + Active participation in Agency/ Industry groups/forums preferred. + Some international travel may be… more
- Takeda Pharmaceuticals (Boston, MA)
- …GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. **How you ... 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 developments in the global technical, regulatory and compliance arena and industry practices. + Apprises CMC Management of plans and risks through regular ... CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. + Excellent communication, leadership and… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Associate Director ** **; CMC , Device Development Program Manager** **Functional Area: Technical ... collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and...5+ years of experience in the biopharmaceutical or biotech industry , with prior experience in a program management role.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for ... of experience with at least 2 + years within CMC Development in the pharmaceutical/biopharmaceutical industry preferred - 4 or More Years Ability to prioritize… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …of our academic community. **Description** The Goizueta Business School is seeking a Director to lead the career development and recruiting efforts for the newly ... in Management (MiM) Program. Reporting to the Assistant Dean & Executive Director for the Undergraduate Career Management Center and collaborating closely with the… more
- AbbVie (South San Francisco, CA)
- …LinkedIn. Job Description Position Description: For the Biologics Drug Product R&D Director position, we are seeking a highly motivated, experienced leader to lead ... of all functional deliverables including reports and applicable quality and regulatory documents. + Implement and manage functional processes and workflows for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. The ... countries worldwide, with headquarters in Foster City, California._ **Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES...incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and approach to engage with trade associations, regulators and other relevant industry stakeholders on key regulatory topics both globally and regionally, ... biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory - CMC function and corporate affairs as needed. In the short… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - West Chester, PA Date: Apr 24, 2024 Location: West Chester, United States, 1938 Company: Teva Pharmaceuticals Job Id: ... with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you will be responsible...of the regional, clinical and Chemistry Manufacturing and Controls ( CMC ) regulatory strategies with the overall global… more
