Regulatory Affairs Manager (CMC)
2 days left
- Full Time
Regulatory Affairs CMC Manager - Surrey
A unique opportunity to work at the heart of ground breaking clinical research into stem cell therapy has arisen for a Senior Regulatory Affairs CMC Specialist. Based in Surrey, and offering a highly competitive salary, this position requires an enthusiastic Regulatory professional equipped with strong experience of Biologics and a good understanding of Advanced Therapeutic Medical Products.
As the Regulatory Affairs Manager, you will be responsible for applying your expert CMC knowledge to the regulatory strategy and submissions of global, cutting edge products.
Your duties will include:
-Provide regulatory CMC strategy into the development of all products
-Preparing, compiling and submitting to global authorities the CMC aspects of any CTAs, MAAs and INDs, as well as any necessary amendments
-To liaise with the internal departments, such as quality and clinical
-Develop and maintain a detailed knowledge of the regulation of ATMPs globally
-Provide CMC regulatory input into non-conformances and change controls and provide regulatory affairs updates to QA metrics.
-To input details of CMC non-substantial amendments to the list of NSAs held within RA and to coordinate submission of these in annual reports or subsequent substantial amendments.
-Act as deputy to the Head of Regulatory Affairs in their absence
-A BSc or higher
-Industry experience of Biologics is essential
- Current knowledge of the regulatory requirements for ATMPs is advantageous
This position comes with a fantastic basic salary and a generous benefits package, as well as the opportunity to work on cutting edge therapeutic projects. To discuss the position in more detail, please contact myself, Emilie Francis, on 0121 616 3477 or email Emilie.firstname.lastname@example.org
CMC, Biologics, Cell therapy, Regulatory Affairs Manager, Wales, Work from home, Clinical Research, Stem Cell, Biotech, Pharmaceutical industry, ATMP, Advanced Therapy, Surrey, Reading, Maidenhead, Slough
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
Apply for Regulatory Affairs Manager (CMC)
Already uploaded your resume? Sign in to apply instantly