- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA… more
- Merck & Co. (Rahway, NJ)
- …regulatory updates.Audit vendors/partners of SaMD/IVD/Companion DiagnosticsReports to - Director Regulatory Compliance, Device Quality and RegulatoryLocation ... Pharmaceutical Process Development, Procurement, Regulations, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC , Regulatory… more
- Merck & Co. (Durham, NC)
- …Division is seeking a highly motivated individual for the role of Associate Director within the Vaccine Manufacturing Facility (VMF) Technology organization. ... The Technical Operations Associate Director will collaborate cross-functionally within the...with internal/external partners, eg other of our company's sites, CMC - Regulatory , Procurement, Supply Chain / Planning, Quality… more
- Eisai, Inc (Exton, PA)
- …well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC , and Clinical Development to collate the ... necessary information to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual (PM) template with inputs from internal and external stakeholders.… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission ... position you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC … more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Lilly (Indianapolis, IN)
- …better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the scientific and ... regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities for Lilly's… more
- Bristol Myers Squibb (Indianapolis, IN)
- …to be the global leader in radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance develops ... and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in Development… more
- Atlantic Health System (Pompton Plains, NJ)
- …revision of procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP, ... medical laboratory technology/ medical or clinical laboratory science preferred + Associate 's degree in chemical, physical or biological science or medical… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION ... : Takeda Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance...of regulatory updates on data, coordinating with regulatory teams (eg, submission publishing, CMC , drug… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical ... compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures...regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development ... Participates on the product development/life-cycle management team to provide regulatory guidance for assigned pharmaceutical products. Primary focus on approved… more
- Merck (Austin, TX)
- … updates. + Audit vendors/partners of SaMD/IVD/Companion Diagnostics **Reports to** - Director Regulatory Compliance, Device Quality and Regulatory ... Pharmaceutical Process Development, Procurement, Regulations, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC , Regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …protocols and reports + Authoring, review, approval and management of high-quality global CMC regulatory submissions and timely responses to agency RTQs + ... Must be able to apply product development expertise to CMC sections of the regulatory filings. +...and/or contractors). + Budget management and sign off at Assoc. Director authorization level, CMC -DP strategy development,… more
- BeOne Medicines (Emeryville, CA)
- **_General Description:_** Sr. Manager/ Associate Director , Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new market launch… more
- Rhythm Pharmaceuticals (Boston, MA)
- …experienced and highly motivated individual to join its team in Boston, Massachusetts. The Associate Director will be the technical lead for Drug Product small ... CMC Drug Substance, Supply Chain Management, Quality, and Regulatory Affairs. + Manages and executes activities related to...as required. + Authors and reviews relevant drug product CMC sections for global regulatory submissions (IND/CTA,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …application is true to the best of my knowledge. **Job Description** ** Associate Director , Clinical Research, Value & Evidence Generation, US Medical** ... in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical… more
- Merck (Durham, NC)
- …Division is seeking a highly motivated individual for the role of Associate Director within the Vaccine Manufacturing Facility (VMF) Technology organization. ... The Technical Operations Associate Director will collaborate cross-functionally within the...with internal/external partners, eg other of our company's sites, CMC - Regulatory , Procurement, Supply Chain / Planning, Quality… more
- University of Southern California (Los Angeles, CA)
- cGMP Associate Director , Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- ... cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all… more
