Regulatory Officer (Pharmaceuticals)

Job Summary

We are seeking a qualified and detail-oriented Regulatory Officer with strong knowledge of pharmaceutical regulations and proven experience in product registration. The successful candidate will ensure that pharmaceutical products comply with national and international regulatory requirements and will manage the preparation and submission of regulatory dossiers.

Key Responsibilities

• ​Prepare, compile, and submit dossiers for pharmaceutical product registration and variations
• ​​Ensure compliance with local and international pharmaceutical regulatory guidelines
• ​​Liaise with regulatory authorities regarding product approvals, renewals, and queries
• ​​Maintain up-to-date knowledge of regulatory requirements and changes in legislation
• ​Review labeling, packaging, and promotional materials for regulatory compliance
• ​​Maintain accurate regulatory documentation and product registration databases

Qualifications and Experience

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field
• Proven experience in pharmaceutical regulatory affairs
• ​​Strong knowledge of drug registration processes and regulatory submissions
• ​​Familiarity with CTD/eCTD formats is an added advantage
• ​​Excellent attention to detail and documentation skills
• ​​Strong communication and organizational abilities

Desirable Skills

• ​Experience working with national drug regulatory authorities
• ​​Ability to manage multiple submissions and deadlines
• ​​Good computer skills and proficiency in regulatory databases