- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of global regulations and guidelines regarding drug development (incl. CMC ), regulatory submissions and corresponding regulatory agency interactions ... is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through...internal and external stakeholders from across functions on key regulatory topics, particularly relating to biologics and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change… more
- Merck & Co. (Rahway, NJ)
- …bioprocessing with a history of peer-reviewed publications and presentationsKnowledge of biologics CMC developmentAdaptability and agility to prioritize and ... and inclusive environment for all. Beyond process development for pipeline biologics , we innovate and build next generation biomanufacturing technologies. Examples… more
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents, and address regulatory inquiries. This… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …and non-GLP) at external CROs per Jazz standards and ensures that global regulatory /compliance requirements are met/exceeded.Critically reviews and edits CRO ... CROs upon internal review and team communication, ensuring consistency with global regulatory and compliance requirements.Provides critical input on discovery… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …strategy, which integrates scientific rationale, clinical development, nonclinical development, regulatory , medical, commercial input, CMC , legal and other ... apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives… more
- Takeda Pharmaceuticals (Boston, MA)
- …(including updates) and communication of proactive regulatory CMC strategies to global CMC regulatory teams and stakeholders in a timely manner + ... capital and financial decisions. + Provides leadership of GRA CMC Biologics & ATMP regulatory ...resources, establish a vision, and collaborate with stakeholders in global Reg CMC and across the enterprise… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of ... required, Advanced Degree preferred. + At least 10 years Regulatory CMC experience (vaccines or biologics...CMC submissions. + Understanding of scientific principles and regulatory CMC requirements relevant to global… more
- Editas Medicine (Cambridge, MA)
- … expertise in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues ... + Accountable for the management and delivery of all CMC regulatory milestones, including global ...with both US FDA and EMA with drugs and/or biologics is required. + Prior BLA, sBLA, NDA or… more
- Teva Pharmaceuticals (West Chester, PA)
- Manager, CMC Regulatory Affairs - West Chester, PA Date: Apr 24, 2024 Location: West Chester, United States, 19380 Company: Teva Pharmaceuticals Job Id: 54241 ... difference with. **How you'll spend your day** As Manager, CMC Regulatory Affairs you will be responsible...(eg, FDA, Health Canada) as well as working with global regulatory colleagues in preparing dossiers for… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …the development, licensure, and marketing of drugs and/or biologics * Participate in global RA meetings and help to develop regulatory strategies to support ... for program-specific discussions, connect the dots across IOPS, proactively identify CMC regulatory issues and suggest appropriate strategies to mitigate… more
- Lilly (Indianapolis, IN)
- …to execute. + Solid understanding of drug development, device development, biologics manufacturing, and global operations. **Additional Information:** + Lilly ... 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
- AbbVie (North Chicago, IL)
- …Biologics Analytical Research & Development ( Biologics ARD) is a global analytical sciences organization responsible for all CMC analytical activities ... Biologics ARD provide unique opportunities to work with global and cross-functional teams to drive exceptional science and...The candidate will serve as analytical lead on internal CMC teams and will work with external parties on… more
- Merck (Kenilworth, NJ)
- …with a history of peer-reviewed publications and presentations + Knowledge of biologics Chemistry, Manufacturing and Control ( CMC ) development + Adaptability and ... **Job Description** **Position Description:** ** Biologics Process Research and Development (R&D) Downstream Principal Scientist** Our Scientists are our Inventors.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …create possible, together. **Job Description** **Key Responsibilities** Senior Manager, Global External Manufacturing Biologics supports uninterrupted supply of ... and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, … more
- AbbVie (North Chicago, IL)
- …Biologics Analytical Research & Development ( Biologics ARD) is a global analytical sciences organization responsible for all CMC analytical activities ... AbbVie Biologics ARD provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development… more
- Merck (Kenilworth, NJ)
- …Research and Development GMP laboratories, Biologics Process Research and Development, Global Quality and Regulatory Affairs- CMC , and our partners in ... **Job Description** The Biologics Analytical Research & Development department of our...+ Authoring and reviewing internal technical reports, sections of regulatory filings (eg, IND, BLA) and external scientific publications… more
- Catalent Pharma Solutions (Kansas City, MO)
- Scientist I, Biologics III **Position Summary:** Catalent Pharma Solutions in Kansas City, MO is hiring a Scientist, Biologics III whose main activities will be ... report data, as required by project contracts within the Biologics Department. The data may be used for submission...Department. The data may be used for submission in regulatory packages, release and stability testing of clinical and… more
- Merck (Rahway, NJ)
- …with both internal and external partners including vendors. + Knowledge of biologics CMC development cycle + Demonstrated ability for taking initiative, ... we partner to deliver the next medical breakthrough. **Position Description:** Biologics Process Research & Development (BPR&D) within our Company's Research… more
- CSL Behring (King Of Prussia, PA)
- …of business objectives and current health authority expectations. o Provides communications between Global Regulatory Affairs CMC and partners within GRA and ... Health Authorities, Industry Associations) and company partners to shape regulatory CMC requirements. You will lead and...the pharmaceutical/health care industry, at least 8 years in Global Regulatory Affairs, Biologics … more
