Regulatory Affairs Manager
3 days ago
**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
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