Senior executive – regulatory affairs

We are seeking a dynamic and detail oriented Senior Executive – Regulatory Affairs to oversee our regulatory compliance and submissions function in line with NMRA requirements.

Key responsibilities

1. Prepare, review, and submit regulatory dossiers (CTD format) for product registrations, renewals, and variations.
2. Ensure compliance with NMRA regulations and applicable regulatory requirements.
3. Coordinate submissions, approvals, and follow-ups with NMRA and other stakeholders.
4. Manage manufacturing site registrations, transport licenses, and regulatory documentation.
5. Monitor regulatory timelines, tender requirements, and compliance activities.
6. Support new product registrations and provide regulatory guidance for product launches.
7. Maintain regulatory records, reports, and communication with principals and partners.

Requirements

1. Bachelor’s degree in pharmacy or a related field.
2. Registered pharmacist with a valid professional license (where applicable).
3. 3–5 years of experience in regulatory affairs within the pharmaceutical industry.
4. Strong knowledge of NMRA procedures and CTD dossier preparation.
5. Excellent communication, coordination, and organizational skills.
6. Ability to manage multiple projects and deadlines with high attention to detail.

Skills & competencies

1. Regulatory compliance
2. Dossier preparation & documentation
3. Stakeholder management
4. Analytical & problem-solving skills
5. Time management & attention to detail
6. Effective communication

When applying

Send us your CV!