Your responsibilities include, but not limited to:
• Internal Stakeholder Relationships
• Assist the Director of Scientific Affairs with meetings, activities, reports, newsletters and projects as required. Monitor and disseminate group inbox for regulatory correspondence.
• Manage health authority portal access and other system administration. Ensure timely processing and payment of invoices for Regulatory Affairs, including raising POs and current vendor requests and reconciling regulatory spend with BPA
• Create, process, and manage purchase orders for external vendors and service providers, incl invoice reconciliation, and compliance with company procurement and financial procedures. Ensure timely reconciliation of department purchasing card statements for Regulatory Affairs department
• Oversee end-to-end RLD sample procurement activities, coordinating orders and deliveries with global vendors and external partners. Oversee regulatory records management,
including maintaining departmental archiving records and assist team members with requests to send or recall items from off-site archiving
• Accountable for accurate and timely entries into various local and global databases and tracking platforms to ensure compliance and knowledge management through Regulatory Information Management (RIM), reporting, tracking of ANZ submission, approval status and post-approval commitments
• Assist in the review and maintenance of local WPs and SOPs to refine processes and procedures in accordance with global SOPs. Assist the Regulatory Affairs Department in the development and collation of dossier including processes and procedures to deliver high-quality published submissions to meet HA requirements for an effective submission.
• Contributes to performance tracking and KPIs of the team to deliver agreed targets and objectives and supports reporting. Contribute to the Regulatory Affairs Department initiatives e.g. process improvements, implementation of
📌 Regulatory Affairs Associate (India)
🏢 Sandoz India
📍 India
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