Senior Regulatory Affairs Officer Role Summary
This is a fantastic opportunity to join our team as a Senior Regulatory Affairs Officer in Dublin. The role offers a permanent position with a hybrid working arrangement, providing an excellent work-life balance.
We are seeking a highly skilled and experienced professional to manage marketing authorization dossiers and submissions for a portfolio of pharmaceutical products. As a Senior Regulatory Affairs Officer, you will be responsible for promoting and leading high-quality regulatory best practices, process efficiencies, effective communication, planning, and delivery of GPA and Corporate projects.
The ideal candidate will have a scientific, pharmaceutical, or Regulatory Affairs degree, along with 3+ years of experience in Regulatory Affairs. They should possess a good knowledge of CTD Module 1 to 5 dossiers and requirements for different types of submissions. Strategic thinking and experience in EU and non-EU international markets are essential for success in this role.
Responsibilities:
* Manage marketing authorization dossiers and submissions (MAAs, lifecycle activities, variations, MA transfer etc.) for a portfolio of pharmaceutical products.
* Promote and lead by example for high quality regulatory best practices, process efficiencies, effective communication, planning and delivery of GPA and Corporate projects.
* Act as a reference and contact person for the product and countries under your responsibility.
* Keep and maintain roadmap and product status for your countries.
* Ensure good communication flow with the affiliates, partners and other departments as relevant.
* Prepare the regulatory strategy for registration of medicinal products and variations in region/country of responsibility in collaboration with local contact(s) as relevant.
* Good overview of registration planning short-term/middle term.
* Prepare and file submissions including: life-cycle maintenance variations, initial MAA fillings, labelling updates, renewals, marketing authorisation transfers.
* Act as mentor and/or contact person for students and junior or external team member(s) as relevant.
* Promote best regulatory practice and approach in business operations.