Senior Regulatory Compliance Officer

1 week ago


Dublin, Dublin City, Ireland beBeeSpecialist Full time €90,000 - €110,000
Regulatory Affairs Specialist Position

We are seeking an experienced Regulatory Affairs Specialist to join our operations as we expand globally.

Key Responsibilities:
  • Prepare high-quality dossiers for marketing authorisation applications, responses to health authority questions, and post-approval submissions.
  • Submit applications to regulatory authorities.
  • Review data intended for submission and advise on any deficiencies or issues.
  • Ensure timely submissions for quality/safety related changes for assigned projects.
  • Prepare translated texts for international markets.
  • Update databases and systems for all products according to current SOPs.
  • Establish effective communication with stakeholders to progress regulatory activities.
Requirements:
  • Masters/Bachelor's degree in Science/Technology/Pharmacy.
  • Minimum 5 years of experience in Regulatory.
  • Strong understanding of health authority expectations for pharmaceuticals in EU/US regions.
  • Excellent organisational, time management, and attention to detail skills.
  • Critical thinking and problem-solving abilities.
  • Strong interpersonal and communication skills.
  • Experience in dealing with multiple stakeholders.
Our Values:
  • Collaboration and customer satisfaction.
  • Creating a workplace culture that encourages creativity, open communication, and mutual respect.


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