Job Opportunity: Regulatory Specialist
We are seeking an experienced and detail-oriented Regulatory Specialist to support global regulatory activities across the full product lifecycle. Reporting to the VP of Quality and Regulatory Affairs and based in Athlone, this role will focus on preparing high-quality regulatory submissions, supporting global regulatory strategies, and ensuring ongoing compliance for a diverse product portfolio. The successful candidate will thrive in a fast-paced, collaborative environment and bring strong technical expertise combined with excellent project management skills.
Job Responsibilities
- Prepare and deliver high-quality regulatory submissions to global health authorities.
- Contribute to and support global regulatory strategies across development and commercial products.
- Author and coordinate submissions for new registrations, post-approval changes, renewals, annual reports, and line extensions.
- Coordinate and contribute to responses to regulatory agency queries and perform quality reviews of submissions.
- Maintain and track submission data, regulatory commitments, and timelines across assigned projects.
- Support the maintenance of existing global regulatory approvals.
- Communicate regulatory issues clearly to stakeholders and present solutions for resolution.
- Manage and contribute to regulatory affairs projects and cross-functional initiatives.
Job Requirements
- Bachelor’s degree (or higher) in Biology, Chemistry, Pharmacy, or a related scientific/technical discipline.
- Minimum of 3 years’ hands-on Regulatory/CMC authoring experience (initial registrations and/or post-approval variations preferred).
- Experience contributing to global regulatory submissions and lifecycle management activities.
- Ability to manage multiple projects concurrently and prioritize workload effectively.
- Strong understanding of regulatory requirements and documentation standards.
- Excellent interpersonal and communication skills with the ability to work cross-functionally.
- High attention to detail, accuracy, and strong organizational skills.
- Resilient and adaptable, with the ability to perform effectively in a fast-paced, evolving environment.
For more information or to apply, please contact: Brian Stack
Email: brian.stack@collinsmcnicholas.ie
Phone: 090 9703030
