Regulatory Affairs Manager

Key Result Areas (Regulatory)

• Adherence to AZ and industry codes of conduct, ethics, PhAMA code & Good Regulatory Practices.
• Maintenance of product licenses to a high standard throughout current year, with zero negative impact to business objectives & financial targets.
• Develop & implement regulatory strategy for responsible therapeutic area to achieve rapid & high-quality approvals & facilitate rapid launch.
• Provide guidance and functional support to regulatory team member.
• Monitor & interpret the local & global regulatory environment for significant changes & communicate implications of such changes to key stakeholders.
• Develop excellent relationships & partnerships with Health Authorities and regulatory KEEs.
• Proactive cross-functional teamwork contributing to optimum business strategies.
• Manage legal (including contracts) & Patent-related matters.
• Manage regulatory vendors and suppliers according to AZ requirements where applicable.
• Act as Company Pharmacist and Poison A License holder for the company.
• As Provisional Registered Pharmacist (PRP) Preceptor for the company (if require).

Typical Accountabilities

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to Regulatory Affairs.
• Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.
• Report potential issues of non-compliance

Education, Qualifications, Skills and Experience

Essential

• Pharmacy or Scientific Degree or equivalent professional qualification in related field
• Minimal 5 years of experience in regulatory affairs area.

• Post-graduate qualification

Key Relationships to reach solutions

Internal

• Country Leadership Team
• Country Cross Functional Team (Quality Assurance, Commercial, Medical, Supply Chain, HR, Finance, Market Access/Tender, Corporate Communications)
• Manufacturing Site, GRAPSQA, Global Supply Chain
• Quality Functional Leadership Teams

External

• Regulatory bodies
• Pharmaceutical companies
• Distributors
• Local Trade Associations
• HCPs & KEEs

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.