Director, Regulatory Affairs

Play a key role in developing the RA strategy of the designed TA, and drive to implement it.

Ensure effective RA activities and deliverable including gaining in-time and high-quality approval and facilitate full speed launch.

Maintain product licenses in assigned portfolio through timely lifecycle management with a high standard.

Maintain the awareness of market intelligence and shape the regulatory environment relevant to the assigned portfolio.

Actively maintain and develop excellent relationship with local regulatory authorities and external stakeholders.

To build and retain effective regulatory team, provide leadership and direction to team; maintain cross-functional communication.

Adherence to AZ and industry code of conduct, ethics and good regulatory practices (GRP) including AZC RA SOPs and other required SOPs, to drive issue management.