Reulatory Affairs Consultant
Input in development, post-approval and life cycle management
Participate in global regulatory team meetings as appropriate;
Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned;
Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.
Liaison with Regulatory Agencies and Local Operating Companies
Liaise with LOCs, track and respond to queries in a timely manner.
Review protocols and ensure alignment with regulatory requirements;
Advise team on required documents and submission strategies in preparation of CTAs;
Ensure CTA submission packages are complete and available according to agreed timelines;
Review and approve clinical trial supply plans.
Provide regulatory support throughout registration process and life-cycle management;
Responsible for the critical review of submission documents to ensure compliance with regulatory requirements;
Responsible for assigned projects to ensure strategic regulatory alignment across all functional areas.
Basic medical/scientific understanding of clinical trials and drug development
Health Authority Expertise
Knowledge of how Health Authorities operates
General knowledge of HA organizational structure and individual responsibilities in those structures
General knowledge of HA timelines for reviewing submissionsEducation and Experience
University degree – medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience.
5 years+ experience in a similar role.
Experience in regulatory affairsInterested candidates should apply via the below link or alternatively send an updated CV to Daniel.Cronin@peglobal.net or call Daniel on 00 353 21 (Apply online only)Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert