Job Summary
As a Senior Regulatory Affairs Officer with our client, a global pharmaceutical company based in Dublin, you will have the opportunity to work on a permanent role with a hybrid offering. This is an excellent chance to join a fast-growing organization with an exciting portfolio pipeline.
Key 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 a roadmap and product status for your countries.
* Ensure good communication flow with 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 contacts 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 a mentor and/or contact person for students and junior or external team members as relevant.
* Promote best regulatory practice and approach in business operations.
Person Profile
* Scientific, pharmaceutical, or Regulatory Affairs degree.
* 3+ years and proven track record of successful Regulatory Affairs experience.
* Experience in EU and non-EU international markets.
* Good knowledge of CTD Module 1 to 5 dossiers and requirements for different types of submissions.
* Strategic mindset for submission planning and local labelling opportunities.