- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and ... for all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence, a typical day might include the following +… more
- Lundbeck (Deerfield, IL)
- Director Global Regulatory Affairs CMC - Remote Opportunity Requisition ID: 5582 Location: Deerfield, Illinois, US Do you want to join a team where the ... of the product (IND/CTAs, NDAs/BLAs, Marketing applications). This role will provide CMC regulatory support and guidance for assigned projects and interfaces… 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. ... Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with product development,… more
- Actalent (Boston, MA)
- Key Duties & Accountabilities: * Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary teams (eg CMC Teams, ... to agency questions, and maintenance activities. * Coordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- Bristol Myers Squibb (Princeton, NJ)
- …Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC , Commercial Manufacturing, etc.) to define and ... alongside some of the brightest minds in biopharma. The Director , CMC Team Leader is responsible for...reviews relevant documents, including but not limited to all CMC regulatory submissions, briefing booklets, information requests,… more
- Astellas Pharma (Westborough, MA)
- …and/or credibility. **Organizational Context:** Reports to Director or Senior Director , Regulatory Affairs CMC . **Qualifications:** **Required** + BS ... Technology, Quality Assurance, Business Partners). Responsible for developing global CMC regulatory strategy (eg, CMC ...in Chemistry or equivalent degree + 10 years industry experience; pharmaceutical companies, CRO or academic with at… more
- AbbVie (North Chicago, IL)
- …abreast of developments in global technical, regulatory and compliance arena and industry practice. + Apprises CMC Management of plans and risks through ... strategy is closely aligned with the clinical and regulatory development strategy. May lead multiple PPDST/ CMC teams from GLP tox through IND and cPoC towards… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to...and 4+ years direct or related CMC regulatory experience + Successful track record in preparation, management… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for ... of experience with at least 2 + years within CMC Development in the pharmaceutical/biopharmaceutical industry preferred - 4 or More Years Ability to prioritize… more
- Lilly (Philadelphia, PA)
- …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... approval of asset in region. + Stay updated on industry trends, technological advancements, and regulatory changes...projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage… more
- AbbVie (Florham Park, NJ)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing statistical ... + Participate in the planning/design, conduct, analysis, and interpretation of CMC studies and regulatory submissions. Participate in establishing departmental… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...passionate about making a tangible impact in the pharmaceutical industry , we invite you to join us in this… more
- Gilead Sciences, Inc. (Foster City, CA)
- …accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. The ... incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. **JOB** **DESCRIPTION** + Drives and supervises team members… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …a device and/or combination product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC ; international experience ... Takeda and externally with stakeholders in HA and in Industry on Material Sciences + Influences changing regulations and...with Takeda teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives… more
- Lilly (Indianapolis, IN)
- …drug development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area + Knowledge ... around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs,...affiliate requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC ...- 7 or More Years 8+ years in pharmaceutical/biopharmaceutical industry experience with a focus on small molecules and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …liaison with the US Food and Drug Administration. * Research information on regulatory CMC standards and departmental policies. * Provide strategic regulatory ... resolution of comments from FDA with assistance from the Director /delegate CMC RA as needed. + NDA...and in collaboration with US RA Labeling Content, provide CMC regulatory support during Annual, CCDS, or… more
- J&J Family of Companies (Titusville, NJ)
- Director , Global Regulatory Leader (GRL) (1 of..., consumer industry or health authority regulated industry + At least 6 years of Regulatory ... Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of...and ensures strategy is in alignment with regional teams, CMC , commercial strategies, and the Target Product Profile +… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called upon to ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works...support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and other functional… more