- Sanofi Group (Morristown, TN)
- …of what you thought was possible. Ready to get started? **Main responsibilities:** + As the Global Regulatory Affairs CMC Lead for Influenza, you will be ... regulatory aspects of influenza team. + Develop global regulatory CMC strategies and...and/or vaccine products) in collaboration with other parts of Global Regulatory Affairs . + Interpret… more
- Takeda Pharmaceuticals (Lexington, MA)
- …my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in ... changing requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on… more
- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with ... the following requirements: Master's degree in Regulatory Affairs or related field plus 2...working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to… more
- Teva Pharmaceuticals (West Chester, PA)
- …a difference, and new people to make a difference with. **The opportunity** The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and ... Senior Director Regulatory Affairs CMC (Biologic...major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ A scientific degree with directly relevant professional experience in small molecule product development, global CMC regulatory affairs , and CMC ... work with Gilead's global portfolio of small molecule products in CMC Regulatory Affairs . This position will lead a global group that ensures "right… more
- Sanofi Group (Cambridge, MA)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally diverse team supporting the… more
- Teva Pharmaceuticals (West Chester, PA)
- Manager, CMC Regulatory Affairs -...(eg, FDA, Health Canada) as well as working with global regulatory colleagues in preparing dossiers for ... difference with. **How you'll spend your day** As Manager, CMC Regulatory Affairs you will...regulatory correspondence to the FDA + Support the global registration initiative for marketed products by liaising with… more
- Takeda Pharmaceuticals (Boston, MA)
- …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 ...regulations and guidelines by applying interpersonal skills and expert Regulatory Affairs Vaccines (RAV) CMC … more
- Danaher Corporation (Marlborough, MA)
- …technical expertise and talent to develop the next generation of life-changing therapeutics. The Regulatory Affairs CMC Officer for Cytiva is responsible for ... internal and partner programs. This position is part of Global Regulatory Compliance in Marlborough and will...authorities on CMC matters. + Leads cGMP CMC regulatory intelligence activities, including proactive communication… more
- Amgen (New Albany, OH)
- …patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager, CMC . **Live** **What you will do** Let's ... all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a...manufacturing and quality programs throughout product lifecycle. + Provide CMC regulatory strategy for products manufactured at… more
- BeiGene (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential** **Functions** **of** **the** **job:** . Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC … more
- Gilead Sciences, Inc. (Foster City, CA)
- …be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. ... analytical flexibility the incumbent will support "right first time" global approvals for CMC control strategies and...CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks. + Demonstrates… more
- Editas Medicine (Cambridge, MA)
- …in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and ... + Accountable for the management and delivery of all CMC regulatory milestones, including global ... affairs and a minimum 8 years in CMC regulatory affairs . + Experience… more
- Insight Global (Rahway, NJ)
- …is looking for a Senior CMC Regulatory Specialist to join the Global Regulatory Affairs organization with a large pharmaceutical company. This role ... products globally. This individual will be responsible for developing CMC regulatory strategies and authoring various .... Skills and Requirements - 5+ years experience in Regulatory Affairs within pharmaceutical industry - Extensive… more
- Organon & Co. (Jersey City, NJ)
- … product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating ... regulatory strategies. + Prepare and review information required for development of regulatory CMC dossiers for commercial products. + Provide input to … more
- Takeda Pharmaceuticals (Boston, MA)
- …to senior management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive ... Director and Head, CMC Regulatory Affairs - Pharmaceuticals....regulatory team in the development and implementation of global CMC regulatory strategies during… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …other relevant regulations. More specifically, the individual will work with the global cross-functional CMC team executing late-stage development in support of ... lead/participate in strategizing/resolving activities related to the resolution of requests from the regulatory agencies. + Function as the CMC QA subject matter… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Global Regulatory Affairs Lead** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The Global Regulatory Affairs Lead ... of relevant pharmaceutical/biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and global ), in early… more
- Kelly Services (Juncos, PR)
- …it's all about finding the job that's just right.** **Responsibilities:** + Support site Regulatory Affairs ("RA") CMC staff, collaborate with the client ... **Sr. Associate Regulatory Affairs , PR** **(Administrative shift)** **At...client products/site. + Works cross functionally with local and global operations and regulatory personnel to coordinate… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs , Marketed Products in Cambridge, MA ... the regulatory pathway and history (including competitive regulatory analysis) by researching pre-clinical, clinical, CMC ...Health Canada, and other international health authorities - Support regulatory team and Global Regulatory … more
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