Our Client, a globally recognized leader in healthcare innovation, based in Athlone, Co. Westmeath, is seeking a Senior 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:
1. Prepare and deliver high-quality CMC regulatory submissions for global agencies
2. Contribute to regulatory strategies and manage submission information, tracking commitments and timelines
3. Collaborate with stakeholders, provide consultation, and resolve regulatory issues
4. Manage submissions for new registrations, post-approval changes, renewals, and line extensions
5. Maintain global regulatory approvals and ensure timely responses to agency queries
6. Lead regulatory affairs-related projects
Essential Criteria:
1. Bachelor's/Graduate degree in a relevant science discipline (Biology, Chemistry, Pharmacy)
2. 3-5 years of Regulatory/CMC authoring experience in a Pharmaceutical company is essential
3. New market access filing and post approvals experience
4. Experience liaising with CMO's
5. Excellent written, oral communication, and project management skills
Core Competencies:
1. Action-oriented, detail-focused, and results-driven
2. Strong leadership, interpersonal, and presentation skills
3. Ability to manage multiple projects and respond effectively to change
For a confidential discussion about this opportunity please contact Ranait Coughlan
ranait.coughlan@collinsmcnicholas.ie
(090) 6450664 (01) 66 200 88
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