Senior Regulatory Compliance Specialist

5 days ago

Co Meath, Ireland beBeeCompliance Full time €90,000 - €150,000
Regulatory Affairs Professional

Key Responsibilities:

  • Maintain regulatory compliance for products in various territories.
  • Implement Type IA, IB, and II Variations effectively.
  • Manage licence transfers across international markets.
  • Review promotional material for medicinal products to ensure accuracy.
  • Prepare Module 1 documentation for National Applications.
  • Participate in meetings with Regulatory Authorities to discuss product approvals.
  • Handle regulatory aspects of internationalising products and applying for reclassification.
  • Train junior team members on Regulatory processes and compliance requirements.
  • Monitor and interpret regulatory trends relevant to the industry.

Requirements:

  • Minimum 3-4 years progressive experience in Regulatory Affairs within the pharmaceutical industry (human health).
  • Demonstrable experience with preparing and submitting dossiers for multiple EU countries.
  • Exceptional attention to detail and outstanding organisational skills are essential.
  • Able to work independently and take responsibility for actions.

Responsibilities Include:

Ensuring regulatory compliance, managing licence transfers, reviewing promotional material, and participating in meetings with Regulatory Authorities.

What We Offer:

A challenging role with opportunities for growth and development, as well as a competitive compensation package.

Benefits:

Opportunities for professional growth and development, competitive compensation, and a dynamic work environment.

Other Information:

This role is ideal for a motivated and experienced Regulatory Affairs professional looking to take their career to the next level.

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