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Manager / associate director

Oxford
Associate director
Posted: 21h ago
Offer description

You will work within development and commercial environments in a Team that is accountable for the successful outsourcing and progression of all chemistry, manufacturing and analytical work undertaken by external contractors. You will share in taking responsibility for the timely output of high-quality data suitable for submission to regulatory authorities. Maintaining an informed awareness of the latest regulatory requirements, you will compile and update CMC documentation, for insertion into regulatory dossiers, in addition to working closely with facilities engaged in related activities. You will also assist with preparation of standard operating procedures, and represent the interests of CMC in our project-based environment. you will work within development and commercial environments in a Team that is accountable for the successful outsourcing and progression of all chemistry, manufacturing and analytical work undertaken by external contractors. You will share in taking responsibility for the timely output of high-quality data suitable for submission to regulatory authorities. Maintaining an informed awareness of the latest regulatory requirements, you will compile and update CMC documentation, for insertion into regulatory dossiers, in addition to working closely with facilities engaged in related activities. You will also assist with preparation of standard operating procedures, and represent the interests of CMC in our project-based environment. a graduate in the life sciences, you will have spent at least ten years in CMC related roles within the pharmaceutical industry. You must be experienced in GMP and familiar with the regulatory and manufacturing environment. You will be an effective communicator at all levels with negotiating skills and attention to details. Skills & Requirements a graduate in the life sciences, you will have spent at least ten years in CMC related roles within the pharmaceutical industry. You must be experienced in GMP and familiar with the regulatory and manufacturing environment. You will be an effective communicator at all levels with negotiating skills and attention to details.

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