Regulatory Affairs Associate
Job Description
The Regulatory Affairs Supervisor will be responsible for ensuring compliance with UAE and international regulatory requirements. The role involves managing product registrations, liaising with health authorities, and ensuring that Medisal Pharma meets all regulatory obligations for its pharmaceutical portfolio.
Key Responsibilities
- Regulatory Compliance & Submissions: Prepare and submit regulatory dossiers, variations, and renewals for IV solutions and injectables.
- Health Authority Liaison: Serve as the primary contact with MOHAP, EDE, and other regulatory bodies for product approvals and compliance matters.
- Labeling & Documentation: Ensure that product labeling, packaging, and promotional materials comply with UAE regulations.
- Audit & Inspections: Support regulatory audits and inspections, ensuring compliance with Good Manufacturing Practices (GMP) and other relevant guidelines.
- Regulatory Intelligence: Monitor changes in UAE, GCC, and international pharmaceutical regulations to ensure ongoing compliance.
- Cross-functional Collaboration: Work closely with quality assurance, production, and supply chain teams to align regulatory requirements with operational goals.
Qualifications & Experience
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field.
- 3+ years of experience in regulatory affairs within the pharmaceutical industry.
- Strong understanding of MOHAP, EDE, and international regulatory guidelines.
- Experience in product registration, renewals, and variations.
- Excellent communication and project management skills.
- Fluency in English; proficiency in Arabic is a plus.
Benefits
- Competitive salary based on experience.
- Career growth and professional development opportunities.
- Health insurance, paid time off, and other standard benefits.
