Senior Manager Regulatory Affairs

1 month ago

Dartford Kent, United Kingdom Qube Recruitment 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 TPBN1_UKTJ

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