AstraZeneca Pharmaceuticals LP Quality Assurance & Regulatory Affairs Manager - Singapore in Singapore

Quality Assurance & Regulatory Affairs Manager - Singapore

At AstraZeneca, we believe in the potential of our people and we’ll develop you beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. As a Quality Assurance & Regulatory Affairs Manager for Singapore, you’ll play a pivotal role in delivering life-changing medicines to patients.

Main Duties & Responsibilities:

  • Develop and implement quality assurance systems (QMS) and processes within the GxP areas (GRP, GMP-GDP, GVP, GCP), aligned with local and global requirements to maintain licence to operate

  • Ensure the effective operational implementation of the QMS appropriate to the GxP discipline

  • Develop and implement regulatory strategies to achieve rapid and high quality approvals and facilitate rapid launch

  • Maintain product licences to high standard

  • Develop excellent relationships and partnerships with Regulatory Authorities and regulatory KOLs

  • Monitor & interpret the local and regional quality & regulatory environment for significant changes and communicate implications of such changes to key stakeholders

Essential Requirements:

  • Bachelor’s degree in Pharmacy or Life Sciences

  • Minimum 5 years' experience of quality assurance in pharmaceutical industry

  • Excellent operational skills and ability to think strategically

  • Able to work cross-functionally to develop specific plan to address different challenges

  • Strong interpersonal and communication skills

  • Team player, organized, results oriented and independent

  • Broad understanding of the commercial, operational and strategic aspects of the pharmaceutical business

This position is not eligible for sponsorship of employment visa/work permit in Singapore.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.