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Regulatory Affairs Submissions Manager - Dublin
Aspen Pharma Group
📍
Dublin, Ireland
Location
Dublin
Posted
June 07, 2026
Commute
Local Area
Local Opportunity Near You!
This job is in your area. Enjoy a short commute and work close to home.
Job Description
- The primary objective of this role is to lead the RA International Submissions Team and oversee all MRP/DCP and global regulatory submissions, ensuring compliant, high-quality documentation, and timely delivery.
- The role also drives regulatory strategy, maintains compliant Marketing Authorisations, and ensures timely product approvals through strong cross-functional collaboration and proactive risk management.
- As the department’s IDMP SME, the role ensures high-quality SPOR/IDMP data, supports data-governance processes, and maintains compliance with evolving regulatory data standards.
- Additionally, it aims to strengthen departmental capability by coaching and developing the Regulatory Affairs team, fostering continuous improvement, and building robust regulatory and data-management expertise across the department.
nternational Submissions Team Management and Submission Strategy:...