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Regulatory Affairs ManagerRef: 1704-2

Salary:£50000 - £54000 per annum + bonus and benefits

Added:22 Nov 2019

Region: South East

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

An excellent opportunity has arisen for a Regulatory Manager / Team Leader to join a global team within a specialist Pharmaceutical company based on the south coast. Within this role you will gain a large amount of exposure working closely with R&D, QA and PV teams and lead a team of Regulatory professionals. Job Specific Responsibilities: - Line manage a team of regulatory officers and senior officer - Ensure regulatory systems, such as Regulatory Database /trackers are implemented and kept up to date. - Work with internal & external customers to provide data and accurate regulatory input - Prepare & review labelling/Packaging text. Promotional reviews *Communicate with regulatory agencies and document communication - Prepare, Review and sign off change control risk assessments - All paper and electronic files kept up to date and easily locatable - Input into team activities e.g. brainstorming, best practices etc. - Prepare & review assigned SOPs - Prepare & review new product dossiers and annual updates - Preparation & review of high quality timely submissions/responses and follow up of actions arising from Regulatory Authority commitments - Review and approval of CTA/IND submission and maintenance documentation - Prepare & review new product dossiers and annual updates Qualifications/Experience required: - Relevant life sciences degree - Minimum of 5+ years in the pharmaceutical field - Ideally previous line management experience - Demonstrated ability to write good quality documents - Communication skills - Attention to detail/accuracy - Project management - Breadth of technical regulatory knowledge & regulatory procedures in a variety of markets - Proficient user of Microsoft Office For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to

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