We are looking for a Senior Regulatory Affairs Executive to join a leading developer, manufacturer and marketer of healthcare products. Reporting to the Director of Regulatory Affairs, you will be responsible for ensuring regulatory compliance of products manufactured on site. Senior Regulatory Affairs Executive will also be responsible for coordinating and preparing submission packages for regulatory agencies.
Overview of Main Responsibilities (full job description available on request):
Comply with SOPs and assist in their development and review
Determine and communicate submission and approval requirements
Assess the acceptability of documentation for submission
Coordinate and prepare submission packages for regulatory agencies
Respond to questions raised by regulatory authorities
Negotiate with regulatory authorities to achieve most favorable conditions for marketing authorizations or variations
Draft Summary of Product Characteristics, Patient Information Leaflets, and packaging
Monitor legislation and professional publications to maintain awareness of current regulatory practice
Review GMP documentation for regulatory compliance
Represent regulatory affairs at internal and external meetings
What the ideal candidate looks like:·
Bachelor’s degree in a scientific discipline
3+ years of experience in regulatory affairs
Experience working in the pharmaceutical industry.
Membership of The Organization for Professionals in Regulatory Affairs (TOPRA) is preferable.
For a confidential discussion and more information on the role, please contact Aisling Lane.