Main Objective of Role
- Working within an environment with an international outlook, manage the team of Regulatory Affairs Officers and submissions process for MRP/DCP procedures, achieving long term account goals in line with the company vision and values
- Manage and oversee the coordination of regulatory submissions assigned to RA International Submissions Team and ensure registration deadlines are met
INTERNATIONAL SUBMISSIONS TEAM MANAGEMENT
- Manage and oversee the coordination of regulatory submissions assigned to RA International Submissions Team and ensure registration deadlines are met
- Ensure that documentation compiled by team is complete and complies with applicable regulatory requirements
- Ensuring that information is exchanged and weekly and monthly reporting is followed by the RA International Submissions Team
TASKS RELATED TO THE RA PLAN
- Assist in the development of regulatory strategy as well as monitoring the impact of the changing regulatory environment on submission strategies.
- Proactively inform the RA Manager and other involved functions regarding all identified risks related to the planned MAA.
- Review of regulatory submissions/MAAs for accuracy, completeness and compliance with EU or relevant Health Authority regulations and relevant guidelines; ensure that all specific national requirements are met.
- Prepare, as per internal process, the data needed to make all required registration fees in a timely manner.
- Dispatch the documentation in the appropriate manner in order to deliver it to the relevant Health Authority or local Regulatory Service Provider or local Marketing Authorisation Holder (MAH); ensure the delivery is confirmed.
- Provide regulatory input to product lifecycle planning, including building of renewal plans, assessing the risk related to 'sunset clause' provision
- Work as part of a team dealing with global registrations and provide regulatory support (guidance and strategy) to multi-disciplinary team and all operational departments within the company.
- Perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.
- Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
- Min 4-5 year experience in a regulatory affairs environment in the pharmaceutical industry preferably with management/supervisory experience
- Detailed knowledge of EU current registration requirements for dossier preparation and procedure running
- Solid knowledge of specific national requirements in EU and other regions
For more information and to apply for this role please call Zoe on +353 1 2784671 or e-mail zhamilton@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671
