Senior Manager Regulatory Affairs

Job title: Regulatory Affairs Senior Manager A global pharmaceutical company with a vast generics portfolio are seeking a Senior Regulatory Affairs Manager. This role will be based from their London office 3 days per week. Responsibilities: Review of the submission and associated documents as per the current regulatory requirement to ensure the correctness of the same for compliance with the regulatory health authorities requirement of filing Contribute to the regulatory strategy by participating in the team discussion and providing regulatory input as per the current guidelines during the initial phase of development till the submission of the dossier to ensure correct documentation and data generation Maintain the market authorisation throughout the product life cycle to ensure the compliance to product quality and safety and by renewing validity/ submitting annual report to ensure availability of the product in market Maintain validity of the marketing authorisation by filing renewal/Annual report (US) to ensure availability of product for placing in market Requirements: Have at least 6year experience managing regulatory activities for EU market. This experience should include Module 1 compilation, artwork requirements & approvals, submission of new Marketing Authorisations Have managed successfully before small regulatory affairs teams (3-5 people). Have good communications skills. Be able to work in a matrix organisation. Be able to create RA strategies for new MAAs and VAs submissions. Salary and benefits: A competitive salary, annual bonus and wider benefits scheme is on offer To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk