- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- BeiGene (Emeryville, CA)
- …stage through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions (INDs/CTDs). + Building scope and ... processes and analytics for cell therapy products. + Assembling relevant CMC data and authoring regulatory filing documents ( CMC sections) and responses to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …development activities and oncology project development. + Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA submission ... The Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible...in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC product strategy based on a cross functionally designed… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. Purpose: The purpose of the Senior Director / Executive Director , Global Regulatory Affairs, Global Regulatory ... drug development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area + Knowledge… more
- Amicus Therapeutics (Princeton, NJ)
- Executive Director , Program Management Location Princeton, NJ Requisition ID 2277 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1323) Executive Director , Program Management Amicus Therapeutics is a… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... of drug candidates to support clinical trials, product commercialization, and regulatory submissions. The position presents an opportunity to lead dynamic teams… more
- Merck (Rahway, NJ)
- …partner with cross-functional development teams to enable pipeline decisions. The Executive Director , Biologics Analytical Research and Development (B-AR&D) is ... the recruiting, appraisal and development of personnel under their supervision. The Executive Director selects, trains, and effectively works with colleagues to… more
- Amicus Therapeutics (Marlow, OK)
- Executive Director , Head of Quality Operations Location Marlow, UK Requisition ID 2266 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1311) Job Brief Executive Director , Head of Quality Operations Amicus… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Executive Director , Global Clinical Supply Chain (GCSC)** **KEY RESPONSIBILITIES:** ... Executive Director , Global Clinical Supply Chain is responsible for leading...clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations. + Prior experience in complex… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as an Executive Director , Global Program Leader (GPL) in our Cambridge office. At Takeda, we ... strong enterprise leaders + be committed to simultaneously driving regulatory approval as well as product launch and global...and risks to TA Unit Head and/or the Takeda executive management governance committees per company process. + Manages… 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 ... development The Director will report to the Executive Director of Vaccine Drug Product Development,...+ Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC . Strong experience in… more
- Merck (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC , formulation functions, and clinical functions to ensure ... in bioperformance of formulations The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 8-10 direct reports composed… more
- Merck (Rahway, NJ)
- **Job Description** Under minimal guidance of the Executive Director / Director /Associate Director , Pharmacovigilance (PV) Partner Strategy & Management ... of PV agreements, PV plans, and SMPs. + Maintains, in collaboration with the Executive Director / Director / Associate Director PV-PSM, the internal… more
- Gilead Sciences, Inc. (Foster City, CA)
- …stakeholders. Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC , Process Development, Supply Chain and other ... regulatory inspections/audits. Participate in writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory… more
- AbbVie (Cambridge, MA)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is responsible for ... the management of global regulatory leads with product and disease state expertise for...to long-range plans to carry out objectives established by executive management. Provides guidance and recommendations to direct reports… more
- Bristol Myers Squibb (Madison, NJ)
- …The Senior Medical Director , US Lymphoma/CLL will report to the Executive Director , US Medical Multiple Myeloma/Lymphoma Disease Lead. He/she will be ... Medical + Clinical Research and Development + Statistics + Translational Research + Regulatory Affairs including CMC - Regulatory + Manufacturing and Quality… more
- Vera Therapeutics (Brisbane, CA)
- …with stakeholders across functions. Responsibilities: * Work closely with commercial, clinical, CMC , finance, regulatory and QA, to create and manage the ... Title: Senior Director , Commercial Supply Chain Management Location: Brisbane, CA...of ICH and FDA guidelines and regulations. Experience with regulatory , QA, and cGMP requirements for biologics. * Proven… more
- AbbVie (Irvine, CA)
- …Research Group at AbbVie seeks an accomplished scientist and leader. The Director /Senior Principal Research Scientist will lead a team performing in vitro and ... productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage… more
- AbbVie (Irvine, CA)
- …Innovation Group at AbbVie seeks an accomplished scientist and leader. The Director /Senior Principal Research Scientist will lead a team performing in vitro and ... productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage… more
- Sumitomo Pharma (Columbus, OH)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , FP&A.** Position serves as a key business partner to the T&Q ... advisor to the T&Q organization, including VPs in Manufacturing, Quality, Supply Chain, CMC , and CPC, as it relates to Operating Expense Management. + Lead key… more