- Regulatory Affairs
Regulatory Consultant (Title dependant on Experience)
Regulatory Professionals are currently collaborating with an awarding winning consultancy based in Hertfordshire. With an excellent reputation in market, this prestigious business is looking for an experience professional to join the team on a permanent basis.
You will be responsible for managing a portfolio of projects that will encompass projects in clinical development, at MAA filing stage and post-approval lifecycle management.
Provide regulatory strategic advice on guidelines, legislation and procedures to clients on assigned projects
Develop regulatory plans to meet project and client goals.
Prepare regulatory submissions including clinical trial applications and amendments, scientific advice requests, PIPs, MAA dossiers and variations.
Manage regulatory approval procedures at both the national and EU level.
Lead regulatory projects on behalf of the client including direct liaison and negotiation with regulatory authorities.
Analyse the regulatory environment for impact on project/plans and the overall business.
Possess working knowledge of scientific and regulatory environment
Life science or pharmacy degree.
At least 5 years experience in EU regulatory affairs.
Develop clear, effective and creative regulatory strategies.
Demonstrate ability to assess priorities and set strategies to align with/ meet business need.
This is an excellent opportunity to be a part of a passionate and award winning team. If you are interested in discussing this role further, then please email your CV to firstname.lastname@example.org or call Kirsty on 01189 522 979 to arrange a confidential discussion.