As a senior member of Int’l Regulatory Affairs RAM community, proactively contribute to the strategy, direction and efficient operation of the group. Develop and deliver departmental performance targets for the Int’l Regulatory organisation.
As a senior member of Int’l Regulatory Affairs RAM community, proactively contribute to the strategy, direction and efficient operation of the group. Develop and deliver departmental performance targets for the Int’l Regulatory organisation.
As a senior member of Int’l Regulatory Affairs RAM community, proactively contribute to the strategy, direction and efficient operation of the group. Develop and deliver departmental performance targets for the Int’l Regulatory organisation.
Ensure compliance with global and local SOPs and report any deviations or compliance concerns immediately and assist in preparing necessary corrective actions and preventive actions (CAPAs) locally for non-compliance issues.
Work with Rollout, Finance, Legal, Commercial and operational teams to ensure regulatory submissions and supporting data are accurate, complete, appropriately approved and supported by an adequate audit trail.
Product Registration: Manage the registration process for M&E products with regulatory authorities, including preparation and submission of documentation, responding to inquiries, and ensuring timely approval.
Collaborate with internal teams, including R&D, Quality Assurance, and Clinical Affairs, to ensure regulatory requirements are integrated into product development and lifecycle management.