- Editas Medicine (Cambridge, MA)
- …of regulatory success, and proposing risk mitigation measures. + Serve as a Regulatory CMC lead on relevant cross-functional or functional teams to ... EMA/FDA/ICH/WHO/Global regulations and regulatory guidance and guidelines. + Lead CMC related interactions with the health authorities including but not… more
- Gilead Sciences, Inc. (Foster City, CA)
- …is responsible for Gilead's global portfolio of small molecule products in CMC Regulatory Affairs. This position will lead a global group that ensures "right ... goals. The role will report directly to Head of CMC Regulatory Affairs at Gilead. **JOB DESCRIPTION** + Lead CMC teams/ groups to support the CMC … more
- J&J Family of Companies (Raritan, NJ)
- …compounds and marketed products according to scientific and risk-based principles. + Participates as regulatory lead on CMC /VCM teams and represents CMC ... Manager Global CMC Regulatory Affairs - 2406185933W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Manager, CMC Regulatory … more
- Lilly (Indianapolis, IN)
- …marketed product support. Responsibilities:: ** Regulatory & Drug Development Expertise** + Lead CMC submission management process by providing knowledge of ... to make life better for people around the world. Organization Overview: The Global CMC Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory … more
- CSL Behring (King Of Prussia, PA)
- …with external (eg Health Authorities, Industry Associations) and company partners to shape regulatory CMC requirements. You will lead and direct strategy ... the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans,...to enable a and planning to future our requirements. Lead regulatory strategies and activities globally -… more
- Takeda Pharmaceuticals (Boston, MA)
- …regulations to ensure CMC compliance within the organization + Lead regulatory compliance assessment with respect to filing requirements for ... where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs...with strategic partners globally. **How you will contribute:** + Lead planning, execution, and management of regulatory … more
- Teva Pharmaceuticals (West Chester, PA)
- …SPONSORSHIP IS AVAILABLE** **How you'll spend your day** + Provide accurate and timely CMC regulatory guidance to teams engaged in the development of new ... to the development teams. + Develop and communicate effective CMC regulatory strategies for development and post...dossiers to be submitted to foreign Health Authorities. + Lead the review of internal CMC controlled… more
- Taiho Oncology (Pleasanton, CA)
- …Join our dynamic and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive Director, Regulatory ... Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all...well in a team environment and the ability to lead others. + Working knowledge of project management. The… more
- J&J Family of Companies (Titusville, NJ)
- …dossier updates and meet regulatory timelines + Prepare, review, manage, and lead responses to CMC related questions from regulatory authorities + ... Scientist, Regulatory CMC Dossier - Biotherapeutics -...Scientist, Regulatory CMC Dossier - Biotherapeutics - 2406181251W **Description** Janssen...in Modules 2 and 3 of the eCTD + Lead CMC team meetings to resolve reviewer… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC ... and the respective development stage of the project. The CMC Lead will support the Sr. ...- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or… more
- Takeda Pharmaceuticals (Boston, MA)
- …Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals regulatory team in the development ... and implementation of global CMC regulatory strategies during development commercialization and... CMC experience including experience as an RA CMC product lead , or equivalent industry experience,… more
- Takeda Pharmaceuticals (Boston, MA)
- …team, develop as well as oversee development (including updates) and communication of proactive regulatory CMC strategies to global CMC regulatory teams ... adoption and registration of new technologies and molecules. + Lead and mentor senior individuals with varying backgrounds, enabling...capital and financial decisions. + Provides leadership of GRA CMC Biologics & ATMP regulatory team and… more
- BeiGene (San Mateo, CA)
- …through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions (INDs/CTDs). + Building scope and ... processes and analytics for cell therapy products. + Assembling relevant CMC data and authoring regulatory filing documents ( CMC sections) and responses to… more
- AbbVie (South San Francisco, CA)
- …deliverables and help drive drugs substance purification development strategy though program lead assignments in cross-functional CMC teams. This position is an ... Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long and… more
- Lilly (Philadelphia, PA)
- …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... seamless execution of CMC strategies and activities. + Lead and...projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage… more
- Insight Global (Rahway, NJ)
- …the various workstreams surrounding process and analytical knowledge transfer along with regulatory authoring the lead will work to address: Efficiently ... Description Working in partnership with IT and the digital CMC workstream leads to define and design the data...meet service target selection needs in the future state. Lead integrated semantic layer that will serve as a… more
- Novo Nordisk (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
- Emory Healthcare/Emory University (Atlanta, GA)
- …community. **Description** The Goizueta Business School is seeking a Director to lead the career development and recruiting efforts for the newly launched Master ... Ensures the preparation of operational and statistical reports for management and regulatory agencies. + Plans, administers and monitors the department's budget. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …process technology development, platform process evolution, and cell culture-related regulatory documentation. **Key Responsibilities:** + Lead cell culture ... leaders to step up, share ideas, listen, learn, and lead . We're welcoming bright, diverse, and imaginative minds; we're...Scientist I, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development - Foster City, CA** At Gilead, we're… more
- Organon & Co. (Plymouth Meeting, PA)
- …Position** The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in ... guidance's, and Company procedures. The Associate Principal Scientist will lead the preparation and submission of CMC ...the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… more