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Senior Regulatory Compliance Specialist

3 weeks ago

Nenagh, County Tipperary, Ireland beBeeRegulatory Full time
Job Title:

Regulatory Compliance Specialist


Description:

We are seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with global regulatory requirements.


About the Role:
  • Lead regulatory strategy for key projects, ensuring compliance with global requirements and regulations.
  • Manage regulatory submissions, including new registrations, post-approval changes, renewals, and technical variations.
  • Track regulatory commitments, assess risks, and provide strategic input on development plans.
  • Act as a scientific and technical resource, mentoring colleagues and sharing expertise.
  • Prepare responses to regulatory authority queries, ensuring timely and high-quality submissions.
  • Stay updated on evolving regulations and assess their impact on existing and future products.
  • Collaborate with internal stakeholders across R&D, Manufacturing, and Regulatory Affairs.
  • Engage with regulatory authorities to support marketing authorisation applications.
  • Review GMP documents such as change controls, deviations, and batch manufacturing records.
  • Represent the company at industry conferences and regulatory advisory committees.

Requirements:

Experience: Minimum 5+ years in Regulatory Affairs within the pharmaceutical industry.

Knowledge: Strong understanding of EU and global regulatory frameworks, including HPRA submissions.

Skills: Excellent project management, communication, and stakeholder engagement.

Education: Degree in Life Sciences, Pharmacy, or a related discipline.

Advantageous: Experience in CMC, post-market surveillance, and regulatory strategy development.


Benefits:

Competitive salary + Annual Incentive Plan

Work with a global pharma leader in an impactful regulatory role

Collaborative environment with strong career development opportunities

Exposure to international markets and regulatory bodies

If you're a regulatory expert looking to take the next step in your career, apply now