Collins Mcnicholas | Regulatory Affairs Specialist

Our Client, a globally recognized leader inhealthcare innovation, based inAthlone, Co. Westmeathis seeking aSenior Regulatory Affairs Specialist to join their team.
The successful person will take charge of managing regulatory activities and projects, developing regulatory strategies for new products, and handling submissions to regulatory authorities while supporting the company's growing regulatory needs.
This is a permanent position offering an attractive benefits package and hybrid arrangements.
Key Responsibilities: Prepare and deliver high-quality CMC regulatory submissions for global agencies Contribute to regulatory strategies and manage submission information, tracking commitments and timelines Collaborate with stakeholders, provide consultation, and resolve regulatory issues Manage submissions for new registrations, post-approval changes, renewals, and line extensions Maintain global regulatory approvals and ensure timely responses to agency queries Lead regulatory affairs-related projects Essential Criteria: Bachelor's/Graduate degree in a relevant science discipline (Biology, Chemistry, Pharmacy) 3-5 years of Regulatory/CMC authoring experience in a Pharmaceutical company is essential New market access filing and post approvals experience Experience liaising with CMO's Excellent written, oral communication, and project management skills Core Competencies: Action-oriented, detail-focused, and results-driven Strong leadership, interpersonal, and presentation skills Ability to manage multiple projects and respond effectively to change For a confidential discussion about this opportunity please contact Ranait Coughlan Skills: Pharma Reg affairs New market access CMC CMO's