Senior Regulatory Affairs Officer
2 days ago
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:- 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 the 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 filings, labeling updates, renewals, marketing authorization 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.
- 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 labeling 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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