Senior Regulatory Affairs Specialist

1 week ago


Dublin, Dublin City, Ireland beBeeRegulatory Full time €50,000 - €55,000
Job Title: Senior Regulatory Affairs Specialist

We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to lead our regulatory operations and manage global marketing authorisation applications (MAAs), new product development, and lifecycle management activities across our portfolio.

The ideal candidate will have several years of regulatory affairs and direct management experience, a scientific degree at Master of Science level, strong leadership and team management skills, excellent organisational skills with the ability to manage multiple priorities, and the ability to communicate efficiently with internal and external stakeholders globally.

This role includes direct line management responsibilities and provides an opportunity to work on a range of projects, from new product development to lifecycle maintenance. You will be responsible for evaluating and proposing the most appropriate regulatory strategy for new product development and life cycle maintenance of our products for global markets.

Key Responsibilities:
  • Evaluate and propose the most appropriate regulatory strategy for new product development and life cycle maintenance of our products for global markets.
  • Provide effective leadership and mentorship to a team of regulatory affairs professionals.
  • Prepare and file regulatory submissions for new marketing authorisations and life cycle management, including labelling updates, renewals, MA transfers etc., review of documentation, and publishing as relevant.
  • Provide input on impact of new change controls on licences in global markets and facilitate implementation of these as relevant.
  • Maintain clear, high-quality communication with internal teams (Quality, Medical, Clinical, Supply Chain, PMO, Pharmacovigilance, Industrial, Legal, and local RA managers) and external stakeholders.
  • Prepare status reports and metrics for assigned projects.
  • Promote best practices in regulatory operations and the use of digital regulatory platforms.
  • Ensure regional regulatory experience and opportunities, obtained through regular regional contacts and collaboration, is fed back into relevant regulatory strategies.
Required Skills and Qualifications:
  • Several years of regulatory affairs and direct management experience.
  • Scientific degree at Master of Science level.
  • Strong leadership and team management skills.
  • Excellent organisational skills with the ability to manage multiple priorities.
  • Ability to communicate efficiently with internal and external stakeholders globally.
Benefits:
  • Competitive salary and benefits package.
  • Opportunity to work on a range of projects and develop your skills and expertise.
  • Collaborative and dynamic work environment.
  • Professional development and growth opportunities.


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