Our Client, a globally recognized leader in healthcare innovation, based in Athlone, Co. Westmeath is seeking a Senior Regulatory Affairs Specialist. In this role, the candidate 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. The Senior Regulatory Affairs Professional will be required to support the business for 6-12 months, with the opportunity for flexible working hours 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.
Experience/Skills:
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.
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
ranait.coughlan@collinsmcnicholas.ie
(090) 6450664 (01) 66 200 88