GLOBAL REGULATORY AFFAIRS CMC jobs in UNITED STATES, United Kingdom #3

Participate in global RA meetings, provide regulatory interpretation, position, and strategies to support CMC/CP prduct... CMC/CP regulatory issues and develop appropriate strategies to mitigate or fix them, independently finds alternative...

flexibility the incumbent will support “right first time” global approvals for CMC control strategies and maintain “right... and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. Knowledge...

Provide CMC regulatory expertise for investigational and marketed products to project teams. Establish CMC regulatory... and guidelines. Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities...

are properly and timely implemented. Provide support to Regulatory CMC managers in developing strategy for development projects..., including assigned projects and back-up projects. Participate in CMC project team meetings and provide Regulatory CMC support...

Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global... of Quality and Regulatory Affairs located in Fargo, ND and will be fully remote. At Aldevron, we combine best-in-class products...

/Integrated Asset Plan (IAP). This goal has to be achieved both as a component of an overall global regulatory approach and ensure... stakeholders. Liaise closely with other GRA teams such as non-clinical, CMC, Labelling and AdPromo through the Regulatory Matrix...

/Integrated Asset Plan (IAP). This goal has to be achieved both as a component of an overall global regulatory approach and ensure... stakeholders. Liaise closely with other GRA teams such as non-clinical, CMC, Labelling and AdPromo through the Regulatory Matrix...

and ophthalmic diseases. POSITION SUMMARY The Director of Global Regulatory Affairs will serve as a pivotal member of the... regulatory/industry experience in both biotech or pharmaceuticals. At least 8 years as the Global Regulatory Affairs lead...

Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs, Marketed Products in Cambridge, MA with the following... regulatory pathway and history (including competitive regulatory analysis) by researching pre-clinical, clinical, CMC and post...

Job title: Global Regulatory Affairs Lead Location: Cambridge, MA or Bridgewater, NJ About the job The Global.../biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and global), in early...

and execute global (with an emphasis on US and EU) CMC regulatory strategies towards regulatory adoption of innovative approaches... for the US and EU, interpret global CMC regulations and provide strategic direction and regulatory guidance that are relevant...

to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts... authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs...

expertise on global regulatory CMC requirements to management and project teams Provides expert advice to product development... and execution of regulatory CMC plans for assigned development and commercial projects leading to successful preparation...

Job Description General Summary: The Associate Director, Regulatory CMC executes multi-product global regulatory..., as well as the interactions and responses with regulatory agencies Develops global CMC regulatory strategies...

. Main Responsibilities Within the Global Regulatory Affairs CMC LCM (Life Cycle Management) team, you will: be the Regulatory-CMC.... Every one of us is Chiesi." Purpose Pursuing and executing global, robust and innovative Regulatory-CMC strategies...

all aspects of regulatory affairs, including Commercial support, CMC and Clinical and a track record of successful submissions... will have a strong background in regulatory affairs and a proven track record of success in developing and registering biologics and biosimilars...

in all aspects of regulatory affairs, including Commercial support, CMC and Clinical and a track record... will have a strong background in regulatory affairs and a proven track record of success in developing and registering biologics and biosimilars...