ProClinical is advertising a vacancy for a Regulatory Manager CMC position with pioneering niche pharmaceutical company that focuses in developing IVF products. This organisation works closely with the medical profession and its customers, particularly in the field of infertility. The position represents an exciting opportunity to join this up-and-coming organisation in their office in the M4 Corridor.
Working alongside regulatory colleagues to transfer over 60 MAs worldwide back to LDC from 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.
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).
Bachelor's degree equivalent or higher qualification within life science.
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.
Reviewing/annotating and approving artworks and labelling.
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.
Consolidation of dossiers into eCTD.