We are seeking an experienced Regulatory Affairs Manager to join a global pharmaceutical leader in a key role.
Job Summary
This position offers the opportunity to lead regulatory activities, manage submissions, and develop global regulatory strategies for new products and existing portfolios.
Key Responsibilities
* Develop and execute regulatory strategy for key projects, ensuring compliance with EU and global requirements, including HPRA submissions.
* Manage the entire lifecycle of regulatory submissions, from initial planning to post-approval changes, renewals, and technical variations.
* Track and assess regulatory commitments, provide strategic input on development plans, and identify areas for improvement.
* Act as a scientific and technical resource, providing guidance and expertise to colleagues across R&D, Manufacturing, and Regulatory Affairs.
* Prepare high-quality responses to regulatory authority queries, ensuring timely submission of all required documents.
* Stay up-to-date with evolving regulations and assess their impact on existing and future products, making recommendations for process improvements.
* Collaborate closely with internal stakeholders to ensure alignment and effective communication across teams.
* Presents information and ideas effectively in written and verbal communications, engaging with regulatory authorities (HPRA and other EU bodies) to support marketing authorisation applications.
* Review GMP documents, such as change controls, deviations, and batch manufacturing records, to ensure compliance with regulatory requirements.
* Represent the company at industry conferences and regulatory advisory committees, staying informed about the latest developments and best practices in the field.
Requirements
Experience: Minimum 5+ years in Regulatory Affairs within the pharmaceutical industry, with a strong understanding of EU and global regulatory frameworks.
Knowledge: Excellent knowledge of EU and global regulatory frameworks, including HPRA submissions, and good understanding of CMC, post-market surveillance, and regulatory strategy development.
Skills: Strong project management, communication, and stakeholder engagement skills, with excellent analytical and problem-solving abilities.
Education: Degree in Life Sciences, Pharmacy, or a related discipline.
Advantageous: Experience in CMC, post-market surveillance, and regulatory strategy development, as well as proficiency in relevant software systems and tools.