- Lilly (Indianapolis, IN)
- …make life better for people around the world. We are seeking an Advisor/Senior Advisor for Global Regulatory Affairs CMC to be a part of the Lilly Global ... Applications, Market Registrations And Post-Approval Submissions. The Research Scientist in Global Regulatory Affairs - CMC will leverage CMC technical… more
- Lilly (Indianapolis, IN)
- …for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the… more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. Grad Intern - Global Regulatory Affairs CMC **What You Will Do** Let's do this. Let's ... you will work in the Global Regulatory Affairs Chemistry, Manufacture, and Controls ( CMC ) organization...Regulatory Affairs Chemistry, Manufacture, and Controls ( CMC ) organization on the team supporting Amgen's commercial product… more
- Gilead Sciences, Inc. (Foster City, CA)
- …project teams. + Develop, implement, and document policies and procedures within the CMC regulatory affairs department under supervision of manager. ... Qualifications** + Master's Degree with 3+ years of industry experience in CMC regulatory affairs ; or Bachelor's Degree with 5+ years of pharmaceutical… more
- AbbVie (North Chicago, IL)
- …and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product ... department. Participates in initiatives internal to RA CMC . Represents CMC regulatory affairs on project initiatives with other functional areas to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Sr. Associate, CMC Regulatory Affairs - Biologics** Gilead Sciences is seeking ... full-time employment role in the capacity of Senior Associate in Gilead's Regulatory Affairs CMC department. **Job Description:** + Responsible for the… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Senior Manager, Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC ... degree. **Experience:** + Minimum 6+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience… more
- Kelly Services (Seattle, WA)
- Kelly(R) Science & Clinical is seeking a Manager, CMC Regulatory Affairs for a direct hire opportunity with one of our clients, a commercial-stage ... in FDA regulated industry + At least 3 years of experience in CMC regulatory affairs + Experience with biologics required cellular therapy experience… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** **Intern - CMC Regulatory Affairs - Biologics** **Foster City, CA** As ... local community volunteer programs. A summer internship is available in the Regulatory Affairs CMC (chemistry, manufacturing and controls) Department at the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …cancer and inflammation, and serious respiratory and cardiovascular conditions. **Director, CMC Regulatory Affairs - Biologics** **Key Responsibilities:** ... The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio.… more
- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for an Associate Director, CMC Regulatory Affairs . This position can be located in Spring House, PA; Horsham, PA; Titusville, ... strategies as new data become available. + Escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Sr. CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical ... Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical… more
- Takeda Pharmaceuticals (Lexington, MA)
- … where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or pos-approval strategies for assigned products ... strategy + Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- BeiGene (San Mateo, CA)
- …aggressive timelines. The individual will provide support to cross-functional teams on regulatory CMC strategies. **Essential Functions of the job:** + Develop ... and implement small molecule regulatory CMC strategies as well as author CTD CMC sections for assigned projects to ensure on-time and high-quality global… more
- Lilly (Indianapolis, IN)
- …market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing… more
- Takeda Pharmaceuticals (Boston, MA)
- …Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior ... Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently plan, execute and manage regulatory submissions for assigned… 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. **How you will contribute:** + Leads the Early Development Pharmaceuticals GRA CMC … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the ... years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry experience… more
- Vera Therapeutics (Brisbane, CA)
- …complete regulatory content that meets current regional requirements. * Represent Regulatory Affairs (Clinical and CMC ) on cross-functional project ... Job Title: Senior Manager, Regulatory CMC Location: Brisbane, CA About...field and 6+ years of relevant experience and demonstrated Regulatory Affairs experience commensurate with the role.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** **Associate Director, Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs :** **_*This is a site based position located in ... for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. **Job Description**… more
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