Sr. Director, - Regulatory Affairs

Job Description

Reporting to the Executive Director, RIIM, this role will be accountable to ensure a holistic Regulatory centric Data Management (RDM) capability and related data centric submissions within GRACS, are implemented and maintained. This role has broad accountabilities for the following: 

• Regulatory Data Management (RDM) Strategy & Regulatory Data Standards Governance  

• Regulatory Compliance and Risk Management for Regulatory Data 

• Direct and Indirect (e.g., partnering with CMC, Labeling, etc) execution activities that support Data-based Submissions (e.g. XEVMPD, IDMP, PQCMC, SPLetc.)  

• Internal & External Stakeholder Engagement and Change Management for Regulatory Data Standards 

The complexity of gathering, organizing, and validating structured data is critical for GRACS and other critical stakeholder areas including PV, Clinical and Supply Chain to ensure that datasets are complete and consistent. Having a robust Regulatory data management capability is critical to maximise connectivity and data flows across our multiple Veeva Vaults. 

This role will enable future proofing of regulatory submissions and ensuring compliance with evolving standards beyond 2025 (i.e. IDMP related activities and submissions to Global Health Authorities). This will result in positioning the Company competitively by streamlining product lifecycle management and helping to accelerate time-to-market. This will also enable building stronger relationships with regulatory authorities through improved transparency and communication. 

Whilst leading a direct and matrixed team of employees, contractors and vendors, the role is also responsible for collaborating effectively with other key stakeholders to drive the strategic direction of the RDM capabilities and data centric submissions. The ability to influence and negotiate with key cross functional Leaders is critical. The Senior Director should have strong managerial experience, a high-level strategic understanding of regulatory data governance and master data management principles, dataflows and activities that occur at global and regional level as well as the requisite capabilities that enable execution of time sensitive strategies. 

This role has considerable responsibilities as it relates to internal and external stakeholder management. Internally, it is critical to define and convince key stakeholders of the value and criticality of the need for Master Data Management at an enterprise level. This includes fostering a culture of data stewardship and ensuring stakeholder engagement throughout the o