Principle Regulatory Executive
The Role:The right candidate will be responsible for preparing high quality documentation for all regulatory submissions; liaising with relevant departments to ensure regulatory requirements for these submissions are met; proactively communicating with regulatory authorities in order to expedite approval of these submissions. Responsibilities * Prepare and submit high quality documentation for all regulatory submissions, following current best practice standards. * Liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met and to proactively communicate with regulatory authorities in order to expedite approval of submissions and provide regulatory advice and support to other areas of the Company. * Prepare and maintain product labelling for appropriate markets in cooperation with local regulatory and commercial contacts. * To actively participate as primary regulatory resource in cross-functional project teams. * Prepare and review plans for submissions within agreed timelines and ensuring alignment with agreed strategy and guide and manage direct reports, if appropriate. * Identify and provide information for incorporation in the Regulatory databases as appropriate. * Provide information on expenditure against budget for inclusion in periodic financial reports. * Maintain the paper and electronic filing systems for assigned products/countries, following Records Retention procedures. * Liaise with company manufacturing sites to ensure all site manufacturing licences are kept in compliance. * Mentor and support junior members of the team (with possible line management responsibilities). Experience / QualificationsQualificationsDegree in a relevant life science subject or equivalent. Competencies * Considerable regulatory experience and general knowledge of worldwide regulatory requirements (including GMP, GLP and GCP). * A full strategic understanding of the drug development principles and processes. * Awareness, understanding and an ability to interpret the ICH guidelines relevant to his/her technical/functional responsibilities, specifically those related to developing a Target Product Profile and delivering a product at the end of the development process. If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.