Senior Regulatory Associate - CMC
ProClinical is currently recruiting for a Senior Regulatory Associate job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They require someone with a background in CMC, particularly module 3. Someone who knows the components of a CMC module and can manage submissions. This role will cover all markets – global including US. The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the lead for a program under supervision. Job Responsibilities: * Assist Regional Regulatory Lead to support pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations) * Collect and / or create country specific document for regulatory filings worldwide * Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments) in collaboration with Regional Regulatory Lead. * Create and maintain product regulatory history documents through IMR/GRIP and appropriately archive all regulatory documents and agency communications * Ensure compliance via timely submissions to regulatory agencies * Coordinate collection of functional documents in support of regulatory applications * As appropriate participate in GRT to support execution of regulatory strategy * Support process improvement initiatives, standards development, and metrics Assist in template development and maintenance * Respond to specific requests from and communicate relevant issues to GRT * Actively support regulatory compliance * Support the development and execution of GRT goalsTo Apply:Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.proclinical.com. A full job description is available on request. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.