Sr. Regulatory Affairs Specialist- Pharmacist
Job Description:
(Health, Safety, Environment, Quality & Regulatory)
for Multinational Chemical industry company
Are you passionate about compliance, quality, and safety in the pharmaceutical industry? Were looking for an experienced HSEQR Specialist to take charge of critical compliance and quality functions, ensuring the highest standards across operations.
Key Responsibilities:
Regulatory Compliance
- Manage import permits, licenses, and custom releases.
- Ensure compliance with Egyptian Drug Authority (EDA) and NFSA importation regulations.
- Handle inspections, audits, and traceability exercises.
- Monitor regulatory changes and ensure ongoing compliance.
HSEQR Systems & Risk Management
- Develop and maintain integrated HSEQR management systems (e.g., ISO 9001, 14001, 45001).
- Conduct risk assessments and implement mitigation strategies.
- Maintain documentation and effective record-keeping systems.
Auditing, Training, and Incident Management
- Lead internal and external audits and workplace inspections.
- Train staff on HSEQR policies and promote a culture of safety and quality.
- Investigate incidents, conduct root cause analysis, and implement preventive measures.
Performance Monitoring & Reporting
- Track key performance indicators (KPIs) and prepare insightful reports.
- Identify trends and recommend continuous improvement actions.
Stakeholder Engagement & Quality Assurance
- Communicate with regulatory authorities and external auditors.
- Ensure product and process quality compliance.
Qualifications:
- Bachelors degree in Pharmacy (Masters is a plus).
- Minimum 2 years of experience in HSEQR roles in the pharmaceutical industry.
- Familiarity with ISO standards and certifications (ISO 9001, 14001) is highly desirable.
- Strong analytical, auditing, and problem-solving skills.
- Excellent communication and reporting capabilities.
- Proficiency with relevant tools and software.
What Were Looking For:
- A detail-oriented professional with high ethical standards.
- Someone who thrives in a structured environment and is committed to continuous improvement.
- A proactive team player who can also take initiative independently.