REGULATORY AFFAIRS OFFICER @ APEX WORKFORCE SOLUTIONS
APEX WORKFORCE SOLUTIONS is looking for a dedicated Regulatory Affairs Officer to join their team in the pharmaceutical industry. The primary responsibility of this role is to prepare, compile, and submit product registration dossiers in both CTD and eCTD formats for local and regional markets. You will serve as a key liaison between the company and regulatory authorities, coordinating with internal departments such as Quality, Production, and Marketing to facilitate timely approvals and respond to technical queries.
In addition to dossier management, the Regulatory Affairs Officer will oversee the full product lifecycle, including renewals, variations, and post-approval commitments. This role involves ensuring that all labeling, packaging, and technical documentation remain strictly compliant with current regulatory frameworks and international standards. A successful candidate will demonstrate a deep understanding of drug development processes and familiarity with GMP and ICH guidelines to maintain high-quality operational standards.
In addition to dossier management, the Regulatory Affairs Officer will oversee the full product lifecycle, including renewals, variations, and post-approval commitments. This role involves ensuring that all labeling, packaging, and technical documentation remain strictly compliant with current regulatory frameworks and international standards. A successful candidate will demonstrate a deep understanding of drug development processes and familiarity with GMP and ICH guidelines to maintain high-quality operational standards.
Key Requirements
Bachelor's degree in Pharmacy (B.Pharm or B.Sc Pharmacy).
Minimum of 2 years' experience in regulatory affairs within the pharmaceutical industry.
Proven experience in dossier preparation and submission (CTD/ECTD).
Understanding of drug development processes and regulatory frameworks.
Familiarity with GMP and ICH guidelines.
Ability to prepare, compile, and submit product registration dossiers for local and regional markets.
Coordinate with internal departments such as Quality, Production, and Marketing to facilitate approvals.
Manage product lifecycle activities including renewals, variations, and post-approval commitments.
Ensure compliance of labeling, packaging, and technical documentation with regulatory requirements.
Excellent communication skills to respond to queries from regulatory authorities.