Senior Manager Regulatory Affairs & Pharmacovigilance

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.