______________________
________________________
______________________
__________________________
______________________
_____________________
______________________
________________________
_____________________
__________________________
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'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
Our client, based in Dartford, were established in 2011. UK owned they are now expanding and are looking to recruit a Senior Manager Regulatory Affairs & Pharmacovigilance. Job Requirements: Define, develop, and leads regional strategies to maximise regulatory and pharmacovigilance success. Effectively communicate the likelihood of pros and cons to Management. Sound knowledge on requirements of MA Transfer in EU territories, which includes requirements of notarisations and translations. Oversight a team of 4 to ensure day to day activities are carried out in Regulatory and Pharmacovigilance. Sound Knowledge of requirements of Minor and Major complex Variations. Ensure that CMC practices are carried out in accordance with the requirements of regulatory bodies. Responsible for reviewing and signing off bio-waiver declarations and quality overall summaries. Support and carry out the Risk Assessments process as required by the business. Provide oversight for the development and maintenance systems to ensure and support Regulatory and Pharmacovigilance compliance requirements are met. Always assure inspection preparedness to support overall corporate strategy. Ensure that procedures are in place and followed for effective working of the regulatory and pharmacovigilance department. Provide organisation with strategic advice for the launch of new products in EU & UK. Responsible for reviewing and signing off the agreements with external contactors. Representing the company with regulatory agencies across UK & EU Monitoring and setting timelines for the team of individuals to meet the deadlines. Monitoring and setting timelines for licence variations and renewal approvals. Qualifications and Experience (as applicable): Educated to degree level in science or equivalent experience. Minimum 10 years plus of experience in the Regulatory Affairs of Medicines, Food supplements and Cosmetics 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. Monday to Friday: Full Time