Regulatory Affairs Manager – Pharma
This is a key leadership role within our organization, where you will lead regulatory activities and manage submissions to support the approval of new products and maintain existing licenses. You will work closely with cross-functional teams to develop global regulatory strategies and ensure compliance with relevant regulations.
Key Responsibilities:
* Lead regulatory strategy for key projects, ensuring compliance with global requirements.
* 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 (HPRA and other EU bodies) 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.
About Our Organization:
We are a global pharmaceutical leader dedicated to delivering innovative medicines that improve patients' lives. Our collaborative environment offers strong career development opportunities and exposure to international markets and regulatory bodies.
Join us in shaping the future of healthcare.