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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.
