Job Purpose
Lead regulatory affairs activities to ensure that all products are registered, maintained, and marketed in compliance with applicable health authority regulations and company policies.
Reporting Line
- Reports to: Head of Operations
- Supervises: Regulatory Affairs Officers / Associates
Key Responsibilities
- Develop and execute regulatory strategies for new registrations, renewals, and variations.
- Prepare, compile, and submit CTD/eCTD dossiers to health authorities.
- Review and approve labeling, packaging, and promotional materials for compliance.
- Communicate with health authorities and respond to regulatory queries.
- Monitor changes in regulatory requirements and ensure timely implementation.
- Coordinate with internal departments (Quality, Supply Chain, Marketing) to ensure compliance with regulations.
- Maintain regulatory databases and filing systems.
- Provide regulatory training and guidance to relevant teams.
- Manage and ensure all regulatory processes achieved to ensure smooth Supply and successful registration on time.
- Provide strategies and ensure all plans are successful achieved on time.
- Establish efficient regulatory team.
Authorities
- Approve regulatory submissions and communications.
- Represent the company in interactions with health authorities.
- Provide regulatory input in cross-functional projects and decision-making.
KPIs (Key Performance Indicators)
- On-time submission and renewal of product registrations.
- Accuracy and compliance of dossiers and labeling.
- Positive outcomes from regulatory inspections and audits.
- Timely implementation of regulatory updates and requirements.
Qualifications & Experience
- Bachelor’s degree in Pharmacy (mandatory), Master’s degree preferred.
- Minimum 5–8 years of experience in Regulatory Affairs, with at least 2 years in a supervisory role.
- Strong knowledge of CTD/eCTD, GMP, and regional/international regulatory guidelines.
- Excellent communication and negotiation skills with regulatory bodies.
- Proficiency in English (written and spoken).
- Problem solving and proactive.