Senior Regulatory Affairs Officer

Job title:

Senior Regulatory Affairs Officer

Company

Thornshaw Scientific Recruitment

Job description

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 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. 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 or call Tina at +353 1 2784701 / 087 6811990. Thornshaw Scientific is a division of the CPL Group.

Expected salary

Location

Dublin

Job date

Wed, 12 Mar 2025 23:27:26 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (jobsineu.net) you saw this job posting.

AddThis Website Tools
Share

Recent Posts

Sales Executive

Job title: Sales Executive Company BMW Group Retail Job description Marshall Hampshire is looking for…

1 minute ago

KAM – Pediatric Oncology

Titlul postului: KAM - Pediatric Oncology Companie Norgine Descrierea postului engagement. Responsible for structured way…

25 minutes ago

Production Scheduler (summer temp)

Job title: Production Scheduler (summer temp) Company Mölnlycke Job description 9.2.2025. Haastattelemme jo hakuaikana ja…

27 minutes ago

Senior Laborant til in vitro screeningsassays

Job title: Senior Laborant til in vitro screeningsassays Company Novo Nordisk Job description 23 scientists…

31 minutes ago

Salata Hazırlama Personeli

İş unvanı: Salata Hazırlama Personeli Şirket [item_sirket] İş tanımı - Müşteri memnuniyetini sağlamak için güler…

36 minutes ago

ADDETTO/A CUSTOMER CARE SETTORE BANCARIO – CORSICO

Job title: ADDETTO/A CUSTOMER CARE SETTORE BANCARIO - CORSICO Company Synergie Job description Synergie Italia…

39 minutes ago
For Apply Button. Please use Non-Amp Version