- Jazz Pharmaceuticals (Palo Alto, CA)
- …plans.Partners with and provides subject matter expertise to key internal functions ( regulatory , Quality, Clinical, CMC and formulations, Product Quality, Drug ... visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description:The Director , Toxicology is accountable for managing the global nonclinical … more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …strategy, which integrates scientific rationale, clinical development, nonclinical development, regulatory , medical, commercial input, CMC , legal and other ... a focus on deep science and innovation, with speed and potential program and regulatory uncertainty or risks as well as maximizing over value for our patients. The… more
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …in 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 vaccine programs...to teams and line management. + Active participation in Agency/ Industry groups/forums preferred. + Some international travel may be… more
- Takeda Pharmaceuticals (Boston, MA)
- …GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. **How you ... regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM… 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
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Associate Director ** **; CMC , Device Development Program Manager** **Functional Area: Technical ... collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and...5+ years of experience in the biopharmaceutical or biotech industry , with prior experience in a program management role.… 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
- Emory Healthcare/Emory University (Atlanta, GA)
- …of our academic community. **Description** The Goizueta Business School is seeking a Director to lead the career development and recruiting efforts for the newly ... in Management (MiM) Program. Reporting to the Assistant Dean & Executive Director for the Undergraduate Career Management Center and collaborating closely with the… 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 ... countries worldwide, with headquarters in Foster City, California._ **Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES...incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations… 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 ... with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and approach to engage with trade associations, regulators and other relevant industry stakeholders on key regulatory topics both globally and regionally, ... biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory - CMC function and corporate affairs as needed. In the short… more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global Strategic Labelling - Remote Opportunity Requisition ID: 5211 Location: Deerfield, Illinois, US Do you want to join a team where ... - Open to candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling, oversees the process… 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
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose** : The purpose of the Sr. Director role in Global Regulatory Affairs (GRA) - Drug Delivery and Digital Health ... is achieved by interacting with teams and regulators to develop successful regulatory strategies and submissions in support of clinical trials and market… more
- Sanofi Group (Bridgewater, NJ)
- **Main responsibilities:** + Leads the US regulatory activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global ... Regulatory Lead (GRL), the Regulatory Specialist leverages...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Sanofi Group (Bridgewater, NJ)
- …the job** **Our team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages and post marketing to ... a later diagnosis. **Main responsibilities:** + Leads the US regulatory post-marketing activities. + As a key member of...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- J&J Family of Companies (Trenton, 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
- J&J Family of Companies (Raritan, NJ)
- Senior Director , Global Regulatory Leader, CAR-T Therapy - 2406186120W **Description** Johnson & Johnson is currently seeking a Senior Director , Global ... supports their efforts to have a positive impact on their communities. The Senior Director , Global Regulatory Leader, CAR-T Therapy will be responsible for the… more
