(Sr.) Director, Regulatory Affairs

Typical Accountabilities

• 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.

Education, Qualifications, Skills and Experience

Essential

Academic / Professional Qualification

• Bachelor degree or above in Pharmacy, Medical, Biology or related field.

Technical / Skills Training

• have a proven track record on performance and reputation from leading pharmaceutical companies.
• Fully understand the current regulatory practices and regulation in China.
• Good networking with regulatory authority.
• Strong ability on team management.
• Strong collaboration across teams.
• Excellent project management skill and experience.
• Excellent verbal and written communication skills and fluent in both oral and written English.
• Able to work with a keen sense of urgency and priority, task oriented with a “Big Picture” approach.

Working Experience

• Minimum 6 years in leading RA TA with successful delivery track record of RA.
• Minimum 15years in leading MNC as regulatory profession and qualified competence. 
• Rich experience in handling complex regulatory projects, various kinds of regulatory submissions/approvals.
• Rich experience in complex regulatory environment assessment.
• Rich experience in crisis management.

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.