Regulatory Affairs Submissions Manager - Dublin

• 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:...