Regulatory Affairs Specialist

Helps to ensure compliant labeling for Gilead medicinal products and assists with the timely management of updates for assigned product(s)
Manages, as appropriate, interactions and communication with local HAs and acts as the main point of contact for the local HAs for specific topics/products under their responsibility
Helps ensure compliance with local law and regulation and consistency with global procedural documents including assisting with the execution of audits and inspections within the affiliate
Supports local process improvements which havean important impact for Regulatory Affairs (RA) and other departments, may assess proposed changes to local procedural documents and impact on existing processes
Supports maintenance of GDP license, as required
Support the management of quality defects and stock out as required
Reviewer for promotional material and submission to HA, if applicable for assigned product(s)
Acts as a local Gilead representative as required by local law e.g.
Deputy Responsible Person PV
Supports local Affiliate, regional, Intl teams on Affiliate matters eg with the management of regulatory systems and trackers
Helps prepare the Company for changes in regulatory legislation and competitor information in the country for assigned product(s) or projects and communicates this internally to stakeholders