Senior regulatory affairs officer

Our client, based in Dartford, were established in 2011. UK owned they are now expanding and are looking to recruit a Senior Regulatory Affairs Officer. Qualifications and Experience (as applicable): * Educated to degree level in science or equivalent experience. * Minimum 5- 7 years of experience in the Regulatory Affairs regulatory experience with new product introduction within the pharmaceutical industry covering both UK National and European regulations * Strong communication and project management skills * Proficiency in the use of MS Office suite (Excel, PowerPoint) * Ability to take initiative and work with different departments as a team player within the organisation * Strong problem-solving and analytical skills. Facilitation and Leadership skills Job Description: * Manage life cycle/ post-authorisation changes for UK relating to CMC, clinical, safety and product Information changes. * Writing, Compiling and Publishing Dossiers for UK National EU Submissions. * Knowledge of requirements of Minor and Major complex Variations. * Compiling information and data for amendments to marketing authorisations. Submitting the variations to marketing authorisations and working with the MHRA and other regulatory bodies to resolve any RFI rsquo;s arising during review of these variations. * Sound knowledge on requirements of MA Transfer in EU territories, which includes requirements of notarisations and translations. * Ensure that CMC practices are carried out in accordance with the requirements of regulatory bodies. * Developing and writing clear explanations (Bio-waiver Justifications, Manufacturing Justifications etc.,) for new product licences and Variations. * Sound knowledge on requirements in development of product information for UK and EU. * Develop and approve artwork components and patient information (SPC, PIL, cartons and labelling) and associated mock-ups. * Prepare Artwork Submissions that include P1 Applications, Article 61 (3) Notifications * Liaise with the External Pharmacovigilance consultants for submission of Safety variations and PSUSA Variations. * Working with specialist computer software and resources; (Eg: ectd). * Experience in uploading the product information to databases like EMC. * Experience in submissions using MHRA and CESP Portals. Monday to Friday. Full Time