- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global CMC ... diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific … more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Information to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is ... a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key...HA meetings); and/or post-approval submissions. In this role, the GRS- CMC Associate Director , Biologics will… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Affairs CMC where you will develop and ... lead the execution of regulatory CMC investigational, registration and/or post-approval strategies...CMC team, you will report to a Senior Director and work with stakeholders across the business. **How… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with ... be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.… 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 ... all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory...health, environment or politics or related degree and: + Associate Director : 15+ years of related experience… more
- Organon & Co. (Plymouth Meeting, PA)
- …Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist ( Associate ... with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and… 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
- 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
- AbbVie (Florham Park, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing ... + 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...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... implementing global regulatory strategies encompassing clinical, non-clinical and CMC ...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Takeda Pharmaceuticals (Boston, MA)
- …ADRs and provide guidance and suggestions for program management including CMC development strategy, regulatory submission strategy, quality/analytical control ... the best of my knowledge. **Job Description** **Objective / Purpose:** + Global CMC program oversight of PS with management of all project-related analytical topics,… more
- Bristol Myers Squibb (Seattle, WA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Associate Director , Cell Therapy Comparability** **Location: Summit, NJ or ... and the ability to help patients are incredible. The ** Associate Director , Cell Therapy Comparability** will lead...outcomes, conclusions, and other critical information. + Collaborate with Regulatory CMC and other key functions to… more
- Lilly (IN)
- …communities through philanthropy and volunteerism. ** ** **Position Summary:** The Associate Director , Clinical Supply Management has responsibility for the ... team members across functions including but not limited to clinical operations, CMC , regulatory affairs, and QA. + Working knowledge of cGMP's (CFR/ICH) and GCP… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your...Proposal (RFP) through contract execution for clinical studies and CMC projects as well as ongoing governance with key… more
- Novo Nordisk (Boulder, CO)
- …are driving change. Are you ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design, development ... in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical...scaling of small molecules, oligonucleotide intermediates and API's. The Associate Director is expected to implement novel… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to the best of my knowledge. **Job Description** **Objective / Purpose:** As an Associate Director in Analytical Development, it is expected that the individual ... regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics + Represents AD and provide guidance to… more
- BeiGene (Emeryville, CA)
- **General Description:** Sr. Manager/ Associate Director , Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... with Contract Manufacturers (CMO) + In partnership with Quality, CMC , Procurement, ensures that innovation, manufacturing performance, cost objectives and… more