Regulatory Affairs Professional
We are seeking a highly skilled Regulatory Affairs Manager to lead our global pharmaceutical regulatory strategy.
* Develop and implement regulatory strategies for key projects, ensuring compliance with international regulations.
* Manage regulatory submissions, including new registrations, post-approval changes, renewals, and technical variations.
* Collaborate with internal stakeholders across R&D, Manufacturing, and Regulatory Affairs to ensure alignment with business objectives.
* Analyze regulatory commitments, assess risks, and provide strategic input on development plans.
* Act as a scientific and technical resource, mentoring colleagues and sharing expertise.
* Stay up-to-date on evolving regulations and assess their impact on existing and future products.
* Represent the company at industry conferences and regulatory advisory committees.
About You
* You have a minimum of 5+ years of experience in Regulatory Affairs within the pharmaceutical industry.
* You possess a strong understanding of EU and global regulatory frameworks, including HPRA submissions.
* You have excellent project management, communication, and stakeholder engagement skills.
* You hold a degree in Life Sciences, Pharmacy, or a related discipline.
Benefits
* A competitive salary package.
* Ongoing career development opportunities.
* Exposure to international markets and regulatory bodies.
Candidates interested in this role should apply now!