Regulatory Affairs Manager

AstraZeneca

Petaling Jaya, Selangor
Tetap
Sepenuh masa

8 hari lepas

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 ExperienceEssential

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 solutionsInternal

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 27-Ogo-2025Closing Date 26-Sep-2025AstraZeneca 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

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