Ema Regulatory Affairs Expert

European Regulatory Affairs Expert

This role requires a seasoned professional with extensive knowledge of European regulatory processes, particularly in the pharmaceutical industry. The ideal candidate will have a strong understanding of EU and UK regulations, as well as experience in managing regulatory submissions and ensuring compliance.

The position involves working closely with the regulatory team to develop and implement procedures for submitting national applications and variations. Additionally, the successful candidate will be responsible for interacting with relevant authorities, including the MHRA and other EU regulatory bodies.

Key responsibilities include :

• Developing and implementing regulatory procedures for submission and approval of products in the UK and Europe
• Managing pre-submission meetings and scientific advice interactions with regulatory authorities
• Overseeing the preparation and submission of national registration dossiers (MRP and DCP) and product labelling for approval
• Collaborating with cross-functional teams to ensure regulatory compliance throughout the product lifecycle

Required qualifications and skills :

Benefits and opportunities :

We are looking for an exceptional individual who can demonstrate their expertise in regulatory affairs and drive our company's success in this critical area.