Sector: Life Sciences
Consultant: Chris Hutchinson
Salary: £50000 - £70000
Job Status: Permanent / Full Time
This is an office-based role, and the ideal candidate will need to be based in Hertfordshire
Regulatory Affairs Manager
My client are now recruiting for a Regulatory Affairs Manager. This is an exciting opportunity, where the right candidate will be working alongside the Senior Vice President on a daily basis, in a supportive environment where you can make a real impact on the company.
Responsibilities will involve:
Working alongside regulatory colleagues to transfer over 60 MAs worldwide back to the current MA holder.
Planning, preparation and submission of MA applications, post approval, variations, renewals, post marketing commitment submissions and other ad hoc activities in support of maintaining MAs in the EU, MENA, Africa, Asia and the UK.
Working alongside the commercial department to determine the viability of entering new markets, and the regulatory requirements, timelines and conditions in these markets.
Reviewing and submitting artwork and labelling changes, including management of third-party artwork house.
Managing external pharmacovigilance and medical information 3rd party agent.
Building and maintaining effective relationships with external clients/partners alongside partner’s regulatory teams.
Managing/supporting a range of changing project demands.
Gap analysis of regulatory documentation, identification of potential challenges and proposal of solutions.
Developing and maintaining strong working knowledge of regulatory guidelines.
Liaising with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
Responsibility for ensuring that all relevant electronic systems are updated and maintained in alignment with regulatory submissions and commitments.
Ensuring all processes are carried out according to guidelines and standard operating procedures (SOPs).
4 – 5 Years’ Experience
Strong knowledge of MHRA regulations
Knowledge of DCP/National and lifecycle maintenance
Authoring & preparation of regulatory packages and documents for submissions
Direct, hands-on experience of MA transfers
Experience working with regulatory agencies to clarify and resolve regulatory matters.
Change Control, Corrective and Preventive Actions (CAPA) & Deviation procedures
Knowledge of EU, Asia and MENA regulations and post approval procedures
Conducting gap analysis and review of dossiers
Implementing falsified medicines directive
Creating and authoring SOPs
Consolidation of dossiers into eCTD
The position is looking to pay up to 70,000 depending experience.
Pension / Bonus / 31 days’ holiday including statutory holidays, plus birthday / Health insurance / Company mobile and laptop
If you are interested in this please get in touch and send your CV, we are looking to interview candidates as soon as possible.