- 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… more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , RA CMC Post Approval Change ... content plans, bundling strategies, and project timelines. Partner with RA CMC Project Leads to verify and...Preferred: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery,… more
- AbbVie (Irvine, CA)
- …. Job Description The Associate Director Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and external partners ... in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass...supplements and variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research… more
- AbbVie (North Chicago, IL)
- …LinkedIn. Job Description The Associate Director Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and external ... to RA CMC . + Represents CMC regulatory affairs on project...Applicants may be considered for the Senior Manager or Associate Director level based on qualifications. This… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** ** Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs :** ... site based position located in Foster City, CA_** The Associate Director , Analytical Regulatory Science,... Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory… more
- Ascendis Pharma (Palo Alto, CA)
- …We 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 ...complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Associate Director , Global Regulatory Affairs ? The job is located in our King of ... is a hybrid position. You will report to the Director of Global Regulatory Affairs ....GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve… more
- Takeda Pharmaceuticals (Columbus, OH)
- …to apply a broad functional knowledge of Regulatory Affairs ( RA ) and Chemistry, Manufacturing, and Controls ( CMC ) domains to influence global strategies ... to improve processes and infrastructure in line with global regulatory expectations and Global Regulatory Affairs (GRA) technology roadmap. + Promotes … more
- Merck (Rahway, NJ)
- …process characterization (PC), process performance qualification (PPQ), risk assessment ( RA ), control strategy, process comparability reports, and/or regulatory ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. Under the general scientific and administrative direction… more
- University of Maryland, Baltimore (Baltimore, MD)
- …in the MS in Regulatory Science program, with a focus on introductory and regulatory affairs aspects of the program, as well as another aspect of the program ... AREAS OF EXPERTISE AND EXPERIENCE_* Regulatory science, including introductory and regulatory affairs aspects, as well deep knowledge in another aspect (eg… more