£48k per year
8 months ago
Regulatory Affairs Manager
The position is responsible for the day-to-day management of UK and Irish medicinal product regulatory licensing activities (MAA's and all national post authorisation activities) along with oversight and management of the client's nutritional products.
- Day to day management and allocation of workload within the department.
- Mentoring, coaching and line management activities of the regulatory team.
- Preparation and submission of regulatory post authorisation activities, such as variations, renewals, new MAA's to MHRA and HPRA.
- Oversight and management of the enteral nutrition borderline substances to ACBS and DHSC
- To assist in the management of the regulatory budget / invoicing activities, including tracking of all regulatory expenditure and budgetary spend.
- Assess provided supporting dossier documentation to ensure adequacy and accuracy for submission.
- Maintain effective communication between the company and the regulatory authorities during assessment of applications to obtain prompt approval.
- Maintain effective communication between corporate and regional regulatory colleagues to obtain necessary information / data for regulatory submissions.
- Assess promotional material against ABPI Code of Practice and relevant national requirements.
- Assess licensed product labelling to ensure compliance with legal and corporate requirevaments.
- Provide a professional, responsive and efficient service at all times.
- To undertake other reasonable duties as assigned by the Head of Regulatory Affairs.
Experience and Qualifications
- Minimum 6-10 years' experience within pharmaceutical regulatory affairs
- 2 years' or significant people management experience
- MAA experience desirable
regulatory affairs / pharmaceuticals / nutrition / market authorisation application / post application / MHRA / HPRA / ACBS / DHSC / submission / Renewals / variations