- 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. (Upper Gwynedd, PA)
- …Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/ Sr Principal Scientist in Pre-approval ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... regulatory leaders.Responsibilities Strategic Leadership Develop and execute comprehensive CMC strategies for pre-clinical, clinical, and commercial-stage biologic products,… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Division / our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC , Statistical Design of Experiments (DOE),… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate...as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in...tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting,… more
- Commercial Metals Company (Irving, TX)
- …team that you need to excel in your role and reach your full potential. As Senior Director of Finance for the Emerging Businesses Group, you will report to and ... Officer. In addition, you will also partner with the Senior Vice President of the Emerging Businesses Group, and...each business unit Ensure all financial practices comply with CMC Policies and regulatory requirements across all… more
- Olema Oncology (San Francisco, CA)
- …feel better, longer. For more information, visit us at www.olema.com. About the Role Director , Regulatory Labeling As the Director , Regulatory Labeling, ... closely with the CMO/CRO labeling specialists, cross-functional project teams including Quality, Regulatory , Clinical Supply and CMC teams Develop and implement… more
- Arrowhead Pharmaceuticals (San Diego, CA)
- …develop and execute regulatory plans. This position will report to the Director , Regulatory Affairs and collaborate with regulatory and other departments ... need. The Position This position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements… more
- NWRPros (Brisbane, CA)
- …and Controls. Our client is seeking a mission-driven and scientifically grounded Sr . Director to lead the formulation, MSAT, and fill/finish operations ... Our client-a clinical-stage genomic medicine company-recently achieved a major regulatory milestone for its lead gene therapy program targeting a rare lysosomal… more
- Lifelancer (London, KY)
- About the job Sr Medical Director Job Title: Sr Medical Director Job Location: London Township, KS, USA Job Location Type: Remote Job Contract Type: ... Full-time Job Seniority Level: Executive Senior Medical Director , Clinical Development (Oncology) Location: US Remote A global, innovation-driven… more
- Clinical Dynamix, Inc. (Florham Park, NJ)
- Job Description - AD/Dir Regulatory Affairs Reports To: SR Director - Regulatory Affairs. *Prepare and review various modules of ANDAs, and responses to ... in a dynamic environment is required. *In-depth knowledge and experience of regulatory CMC documents review, and approval is required. *Provide regulatory … more
- Eli Lilly and Company (Indianapolis, IN)
- …analytical chemists, bioconjugation scientists, biologics development team, engineers, CMC project management, Lilly manufacturing partners, and regulatory ... portfolio of ADCs that require thorough drug-linker process development and regulatory submission strategies, often with compressed timelines. Collaborate with other… more
- MannKind Corporation (Bedford, MA)
- …voice matters and every contribution counts. Position Summary: We are seeking an Executive Director of Pharmacology to join our R&D team. This role will support our ... Lead Pharmacology/PK/PD activities on multiple projects; collaborate with R&D senior management to align scientific approaches with business objectives. Partner… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. You… more
- Bristol Myers Squibb (Indianapolis, IN)
- …in radiopharmaceuticals . We are seeking an experienced and motivated ** Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing...care resources. Other perks like tuition reimbursement and a recognition program. If you come across a role that… more
- Lilly (Indianapolis, IN)
- …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...strategies for both development and commercial products. Additionally, the Senior Director is committed to encouraging continuous… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC technical ... make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines to… 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. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- Boehringer Ingelheim (Ridgefield, CT)
- …of increasing regulatory complexity and/or business impact. The Senior Associate Director , US Product CMC Regulatory Affairs is responsible for the ... and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory ...relevant topics. Additionally, with support and guidance from the Sr . Associate Director / Director ,… more
