- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** The Associate Director , CMC Regulatory Affairs for Biologics ... This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is seeking a dedicated and innovative Director /Senior Associate Director , Global Regulatory Affairs CMC for Chemical products to join ... Boehringer Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate ...requiring extraordinary regulatory expertise within Group Global CMC Regulatory Affairs. + Support complex, non-standard… more
- AbbVie (North Chicago, IL)
- …YouTube and LinkedIn. Job Description The Associate 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...Applicants may be considered for the Senior Manager or Associate Director level based on qualifications. This… more
- Gilead Sciences, Inc. (Foster City, CA)
- …create possible, together. **Job Description** ** Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs:** **_*This ... site based position located in Foster City, CA_** The Associate Director , Analytical Regulatory Science,...for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as the Associate Director , CMC Program Lead in Allogeneic Cell Therapies. You ... will be responsible to collaborate across Cell Therapy CMC functions and RA functions to deliver CMC pipeline and CMC platform projects. You will sit within… 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 (Worcester, MA)
- …@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
- Sumitomo Pharma (Columbus, OH)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs** . The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… 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
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Associate Director , Global Regulatory Affairs? The job is located in our ... is a hybrid position. You will report to the Director of Global Regulatory Affairs. **Responsibilities:** You...GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve… 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
- ManpowerGroup (Overland Park, KS)
- HIRING a Regulatory Affairs Associate for a **global** **leading...the team are a senior director of regulatory affairs and a CMC Health person. They ... Thorough understanding of **clinical research, drug development process and applicable regulatory guidance** + Knowledge of ** CMC , pharmaceutical manufacturing,… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- We are seeking an Associate Director within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY. This role will lead clinical and ... and captures efficiencies. + Key contributor to high quality CMC regulatory filings, approvals, and commercialization of drug products. Ensures compliance… 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
- Abeona (Cleveland, OH)
- The Associate Director Quality Control (QC) will...overall QC operations + Assist in the preparation of CMC regulatory submissions + Interact with the ... oversee the operation of the QC Microbiology and Transport functions. The Director is responsible for supporting the QC testing, utility and environmental monitoring… more
- Merck (West Point, PA)
- …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure development of robust ... regulatory posture + Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC . Strong experience in safety and environmental… more
- Merck (North Wales, PA)
- …& Division organization of our company. ** ** **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early Drug ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
- J&J Family of Companies (Spring House, PA)
- Johnson & Johnson is recruiting for an Associate Director , Cell Therapy Process Development based in Spring House, PA. At Johnson & Johnson, we believe health is ... we all belong. We are looking for an energetic and highly motivated Associate Director candidate with demonstrated expertise in autologous cell therapy process… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking an enthusiastic ** Associate Director , Program & Portfolio Management** to drive programs forward at Regeneron Cell Medicines (RCM) through ... on programs that are in IND-enabling studies through clinical study execution. **As an Associate Director , Program & Portfolio Management at RCM, a typical day… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Program Management, GI2 TAU in our Cambridge, MA office. At ... significant experience within related functions (eg Clinical Science, Clinical Operations, Research, Regulatory , CMC , Marketing) * Minimum of 5 years program… more