Regulatory Affairs Associate Review

Expertly managed regulatory documents and systems, ensuring compliance with established procedures and regulatory requirements through efficient uploading and tracking. • Strategically planned, prepared, and executed simple submissions, while providing support in the preparation and planning of regulatory dispatches. • Acted as the primary liaison with Health Authority (HA) and its systems for designated regulatory tasks, including management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, and use of HA portals. • Assumed responsibility for ordering and tracking specific regulatory requirements, such as Registration samples, Certificates of Pharmaceutical Product, and Legal documentation, including Letters of Authorisation and Powers of Attorney, as well as translations of regulatory documentation. • Offered support across the organization for assigned non-drug project roles and responsibilities, acting as a designated point of contact or superuser. • Provided coaching, mentoring, and knowledge sharing within the Regulatory Affairs and Management (RAM) skill group. • Contributed to process improvement initiatives for enhanced efficiency and effectiveness.

Yes

AstraZeneca is a company that invests in its employees are always provides opportunity for its employees to grow.

To apply straight away to get started on a prosperous career with the company.