Senior Regulatory Affairs Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €60,000 - €80,000
Job Title: Senior Regulatory Affairs Specialist

This role is perfect for someone who wants to make a real impact in the pharmaceutical industry. As a Senior Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to achieve business goals.


Job Description:
  • Develop and implement regulatory strategies to ensure compliance with EU and other regions' current registration requirements.
  • Compile and review dossiers for accuracy, completeness, and compliance with relevant guidelines.
  • Collaborate with cross-functional teams to develop and maintain Marketing Authorization Applications (MAA).
  • Ensure timely submission of documents to Health Authorities and local Regulatory Service Providers/local MAH.
  • Communicate effectively with internal/external contacts regarding regulatory queries and deficiencies.
Required Skills and Qualifications:
  • Life sciences or pharmacy degree.
  • At least 4-5 years of experience in a regulatory affairs environment.
  • Excellent knowledge of EU and other regions' current registration requirements.
  • Solid understanding of specific national requirements in EU and other regions.
  • Proficient in IT tools specific to RA and pharmaceutical sector.
Benefits:
  • Competitive salary and benefits package.

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