Senior Associate Regulatory Affairs
An exciting opportunity has arisen at a leading biopharmaceutical organisation with extensive experience in discovering, developing and manufacturing innovative human therapeutics. The opening is for a Senior Associate Regulatory Affairs at their base in Uxbridge, this a truly global company with over 17,000 employees worldwide. 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. 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)Job Responsibilities: * 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 goalsSkills and Requirements: * Strong communication skills - oral and written * Organizational skills * Understanding of drug development process; knowledge of CMC requirements, especially country specific documents for international filings * Ability to multi-task in a fast-paced environment.To 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.