Drug registration

• Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timeline, supply strategy.
• Prepare qualified regulatory submission and handle product registrations for new, renewal and variation applications.
• Monitor registration process to ensure timely submission, approvals of new product registration, license extension, and regulatory changes, in line with company strategic business goals.
• Develop artwork required for packaging to secure new product launching and secure stock for sales.
• Provide detailed information on regulatory status of affected products, and advise on appropriate regulatory processes to X-functions.

Promotional material registration

• Review promotional material, support Marketing to revise in accordance with DAV’s requirements.
• Submit dossier in time and follow up the submission/approval process.
• Review product information that published on MIMS/VIDAL

QA activities:

• Assist on QA & QMS activities to ensure AZ MC’s activities performed under GxP.
• Assist to handle Product quality complaint/ product recall, counterfeit, suspected illegal product.

Other duties

• Hospital tender supports: provide documents (GMP, CoA, CPP,..), AZ letter (explanation/commitment,.) to support hospital tender application.
• Update regulatory environment on time to X-functions, Global team.  

External activities

• Initiate, maintain and build up the external relationships with regulatory authorities (DAV), external stakeholders if assigned to successful regulatory outcomes and a positive company reputation.
• Actively collect all relevant regulatory information to report to relevant team for appropriate action.

Adherence to AZ and industry code of conduct, ethics, pharma code and good regulatory practices and ensure high standard of regulatory practices.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.