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Senior Regulatory Affairs Professional

3 weeks ago

Dublin, Dublin City, Ireland beBeeregulatory Full time €85,000 - €110,000

Regulatory Affairs Senior Specialist Role

We are seeking a highly skilled Regulatory Affairs Senior Specialist to join our team. This is an exciting opportunity for a motivated and experienced professional to contribute to the success of our organisation.

Job Description

The successful candidate will be responsible for managing regulatory affairs across all aspects of our business, including existing licensed products and those under development. They will work closely with internal stakeholders to ensure compliance with health authority expectations and industry best practice.

Key Responsibilities

  1. Prepare and maintain high-quality dossiers for marketing authorisation applications, responses to health authority questions, and post-approval submissions.
  2. Submit CPP and manufacturing authorisation requests to HPRA/MHRA.
  3. Review data intended for submission and advise on any deficiencies or issues.
  4. Ensure timely submissions for quality and safety-related changes for assigned projects.
  5. Prepare and submit translated texts to EU and non-EU countries.
  6. Update databases and systems for all products in line with current SOPs.
  7. Liaise with third parties as required to establish effective communication and relationships.
  8. Liaise closely with Business Development, Product Launch, Artwork, Supply Chain, and Quality colleagues to ensure alignment in all initiatives.
  9. Advise management on the status and progress of assigned projects, identifying potential problems or delays, and possible solutions.
  10. Maintain awareness of regulatory requirements and use this information to optimise departmental procedures and processes.

Required Skills and Qualifications

To be successful in this role, you will need:

  • A Master's or Bachelor's degree in Science, Technology, or Pharmacy.
  • A minimum of 5 years' experience in regulatory affairs.
  • Capability to understand health authority expectations for pharmaceuticals in EU, US, and ROW regions.
  • Excellent organisation skills, time management skills, and attention to detail.
  • Strong critical thinking and problem-solving abilities.
  • Excellent interpersonal and communication skills.

About Us

We are a dynamic and innovative company dedicated to developing and manufacturing patient-friendly pharmaceutical products for international markets. We offer a collaborative and supportive work environment, opportunities for career growth and development, and a competitive compensation package.