- Actalent (Boston, MA)
- Position: Director /Sr. Director of Regulatory CMC Location: Charlestown, MA About the Role We are seeking a creative and agile regulatory ... professional to join our collaborative team as the Director /Sr. Director of Regulatory CMC . This pivotal role involves providing leadership for our… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is responsible for ... product in Gilead's global portfolio of biological products in CMC Regulatory Affairs. This position will provide...by maintaining the global licensures. In addition, the Sr Director will be accountable for leading the interpretation and… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global ... CMC regulatory activities for Lilly/Avid diagnostic radiopharmaceutical products. This includes...radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing… 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
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal ... and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy… 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
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... policy and standards for all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence, a typical day might include the… more
- Astellas Pharma (Westborough, MA)
- …and/or credibility. **Organizational Context:** Reports to Director or Senior Director , Regulatory Affairs CMC . **Qualifications:** **Required** + BS ... Pharmaceutical Technology, Quality Assurance, Business Partners). Responsible for developing global CMC regulatory strategy (eg, CMC strategy/planning for… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. RA… 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
- 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
- Amicus Therapeutics (Marlow, OK)
- …and ensuring seamless communication. The incumbent will manage, prepare & execute the CMC regulatory strategy for technology transfer of small and large molecule ... Director , CMC RA Location Marlow, UK...programs. The candidate will ensure all CMC regulatory submissions (such as pre-submission consultation… 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
- AbbVie (North Chicago, IL)
- …and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy. May lead multiple PPDST/ CMC teams from GLP tox through ... CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. *Multiple product development experiences… more
- AbbVie (North Chicago, IL)
- …strong negotiating, influencing, and leadership skills. + Manages completion of CMC regulatory submission documentation for multiple projects of moderate ... the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams… more
- BeiGene (Emeryville, CA)
- …stage 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... experience and 4+ years direct or related CMC regulatory experience + Successful track record in preparation, management of review and approval of NDA/MAA/BLA… 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 ... areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more
- Lilly (Philadelphia, PA)
- …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... and supply projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage people and drive engagement among teams.… 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