Regulatory Affairs Specialist

5 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €110,000
Regulatory Affairs Specialist - Pharmaceutical Industry

This is a permanent full-time role based in Dublin, with the primary focus on regulatory affairs. The successful candidate will be responsible for ensuring compliance with health authority requirements and regulations.

Key Responsibilities

The Regulatory Affairs Specialist will be involved in all aspects of regulatory affairs, including:

  • Preparation and Maintenance of High-Quality Dossiers: Preparation and maintenance of high-quality dossiers for marketing authorisation applications, responses to health authority questions, and post-approval submissions.
  • Submission of CPP/Manufacturing Authorisation Requests: Submission of CPP/manufacturing authorisation requests to HPRA/MHRA.
  • Data Review and Advice: Review of data intended for submission and advise regarding any deficiencies or issues.
  • Timely Submissions: Ensure timely submissions for all quality/safety related changes for assigned projects.
  • Translated Texts: Preparation and submission of translated texts to EU/non-EU countries.
  • Database Updates: Update of databases and systems for all products (in-line with current SOPs).
  • Liaison with 3rd Parties: Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities.
Requirements

The ideal candidate will have:

  • Master's/Bachelor's Degree: Master's/Bachelor's degree or equivalent in Science/Technology/Pharmacy.
  • Regulatory Experience: Minimum 5 years of experience in Regulatory.
  • Health Authority Expectations: Capable of understanding health authority expectations for pharmaceuticals for EU/US/ROW regions.
  • Organisational Skills: Must possess organisation skills, time management skills and attention to detail.
  • Critical Thinking: Excellent critical thinking and problem-solving abilities.
  • Communication Skills: Strong interpersonal and communication skills.

We are looking for a motivated and experienced Regulatory Affairs Specialist to join our team.

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