Senior Regulatory Affairs Officer

4 weeks ago

Dublin, Dublin City, Ireland Thornshaw Scientific Recruitment 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 an exciting portfolio pipeline.

The role & responsibilities:
  1. Manage marketing authorization dossiers and submissions (MAAs, lifecycle activities, variations, MA transfer etc.) for a portfolio of pharmaceutical products.
  2. Promote and lead by example for high-quality regulatory best practices, process efficiencies, effective communication, planning and delivery of GPA and Corporate projects.
  3. 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.
  4. 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.
  5. Prepare and file submissions including: life-cycle maintenance variations, initial MAA fillings, labelling updates, renewals, marketing authorisation transfers.
  6. Act as mentor and/or contact person for students and junior or external team member(s) as relevant.
  7. Promote best regulatory practice and approach in business operations.
Person profile:
  1. Scientific, pharmaceutical, or Regulatory Affairs degree.
  2. 3+ years and proven track record of successful Regulatory Affairs experience.
  3. Experience in EU and non-EU international markets.
  4. Good knowledge of CTD Module 1 to 5 dossiers and requirements for different types of submissions.
  5. Strategic mindset for submission planning and local labelling opportunities.

For full details, email your CV to or call Tina at. Thornshaw Scientific is a division of the CPL Group.

#LI-TD1

Skills:
Senior RA Officer, Regulatory Specialist, Regulatory Affairs

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