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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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Coordinate document authoring and reviews with various groups outside of DPD such as Process R&D Operations S&T, preclinical safety, PK, and QA. Interface with CMC Regulatory personnel to ensure consistency across projects.
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The Energy Manager's primary function will be to negotiate and manage electricity and natural gas contracts / agreements / programs for CMC facilities and to promote / support energy policy important to CMC before legislative bodies, regulatory authorities, utilities, and other external bodies.
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Knowledge of CMC regulatory requirements for advanced therapies and/or biologics during development and post-approval. Provide strategic CMC regulatory expertise for development project teamsProvide strategic input to development & GO teams to mitigate drug supply issues.
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Whether you will spend your day in an office cubicle, operating a crane or running the melt shop at one of our mills, at CMC, you’ll get the training and support from your team that you need to excel in your role and reach your full potential.
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Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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Partners with Client GRA CMC (regulatory scientists) develop complex regulatory strategies. Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRCMC regulatory scientists.
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Immediate need for a talented CMC Regulatory Technical Writer II. He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs.
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If you’re ready to reimagine ways to make the steel industry more sustainable, reinforce the bridges and roadways connecting our communities, and do meaningful work, you’re ready to join CMC. Our success comes from finding, retaining, and supporting the highest quality talent by offering: Competitive compensation Advancement opportunities Training Paid time off Low-cost medical, dental, vision Company-paid life and disability Company matching 401(k) plan Employee stock purchase plan Why CMC CMC provides an excellent opportunity to learn the steel industry and grow in your career.
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Collaborate with cross-functional internal teams (Business Development, R&D, Pre-clinical, Clinical and Regulatory) to achieve CMC program goals and timelines. Drive execution of the CMC strategy for nonclinical and clinical programs by researching and designing experiments for radiopharmaceutical formulation development in preparation for CDMO technology transfer and validation activities.
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This position will work in tandem with CMC and CMC Foundation leadership in identifying and securing appointments with community members; inclusive of assisting and working with CMC Foundation Board members (and assigned County Trustee(s) when appropriate) as an identifier, connector and college ambassador with local prospects and community members.
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cmc regulatory jobs Company: Lilly
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