Associate Director, Regulatory Affairs

Key Responsibilities

• Strategy and External Influence
  • Lead Taiwan regulatory strategy definition and execution for complex programs and key milestones; provide expert regulatory advice to guide cross-functional decision-making.
  • Engage and influence regulatory agencies and trade associations on product and legislative topics; monitor and interpret regulatory environment changes in Taiwan and translate them into actionable strategies.
  • Represent the company on external association committees to ensure corporate perspectives on key issues are clearly communicated and understood.
• Submissions and Compliance
  • Lead planning, authoring (as needed), and delivery of submissions across the product lifecycle (clinical, registration, line extensions, and post-approval maintenance), ensuring timelines, quality, and risk control.
  • Develop and maintain high-quality regulatory strategy documents with robust risk assessments and mitigation plans; provide expertise on Health Authority briefing materials and responses.
  • Ensure market license compliance is maintained in Taiwan; establish improvement plans to close compliance gaps and support training to elevate quality and compliance knowledge in Taiwan.
• Cross-Functional and Matrix Collaboration
  • Serve as the key regulatory lead in Taiwan brand/delivery/product teams to enable rapid, effective submissions and approvals.
  • Contribute to development programs with interpretive input on market legislation and requirements impacting new and existing registrations; drive alignment across R&D, Manufacturing, and Commercial.
  • Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration    

Essential

• Bachelor’s Degree in Science or related discipline, advanced degree a plus.
• Significant experience in regulatory drug development, manufacturing, commercialization, or equivalent; familiarity with clinical, registration, line extension, and post-approval maintenance processes.
• Proven strategic leadership and project management success within a matrix organization, driving cross-functional collaboration and delivery.
• Knowledge of regulatory procedures and legislation; practical experience interacting with Health Authorities; experience at a regulatory agency is a plus.

Desirable

• Demonstrated regulatory leadership across projects; strong strategic influencing and negotiation skills.
• Strong commercial awareness and results orientation; data- and risk-informed decision support.
• Excellent problem-solving and stakeholder management; builds collaborative working relationships and empowers teams.

Date Posted

25-Nov-2025

Closing Date

29-Jun-2026

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.

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 authorisation and employment eligibility verification requirements.