Senior Regulatory Affairs Officer

4 weeks ago

Dublin, Ireland Cpl Healthcare Full time

On behalf of my client, a global pharmaceutical company, we have a new vacancy for a Senior Regulatory Affairs Officer to join the team in Dublin.This is a permanent role with hybrid offering.

Fantastic opportunity to join a fast growing organisation with exciting portfolio pipeline.

The role & responsibilities:

Manage marketing authorization dossiersand 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.

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

For full details email your CV to tdunne@thornshaw.com or call Tina at +353 1 2784701 / 087 6811990.Thornshaw Scientific is a division of the CPL Group.www.thornshaw.com

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