Officer Regulatory Affairs

Job Summary

The Officer Regulatory Affairs will be required to support the company by shaping regulatory strategy and ensuring medicines are approved, compliant, and sustainable on the market. This involves acting as a bridge between the company and health authorities, translating regulatory requirements into practical action across the entire product lifecycle, securing and maintaining regulatory approvals and ensuring ongoing compliance with regional and global requirements.

Key Responsibilities

• Product Lifecycle Management: preparing and submitting applications for marketing authorisations (product licenses), responding to queries from regulators and contributing to negotiations where needed, managing post-approval changes, renewals, and variations to maintain product compliance in the market.
• Regulatory Submissions & Strategy: participating in developing regulatory strategies that align with business objectives and scientific goals as well as advising the company and partners on regulatory pathway optimization to accelerate time-to-market.
• Compliance management: Ensuring products meet Local and international regulatory requirements for the markets where they will be supplied.
• Gather, collate and critically evaluate scientific and technical data to support regulatory submissions as well as managing response strategies for regulatory queries and requests for additional information.
• Manage regulatory timelines, track milestones/commitments and coordinate input from departments such as research and development (R&D), clinical, quality and manufacturing
• Regulatory authority interactions; Maintaining productive relationships with regulatory authorities and other partners.
• Labeling and Advertising Review: Review and approval of artworks, packaging, labels, and promotional materials.
• Regulatory Intelligence: Staying updated on evolving regulations in the pharmaceutical industry and advising internal teams on regulatory impact.
• Ensuring proper record keeping, documentation and tracking of regulatory activities as per internal quality management system.
• Advise and participate in quality management system reviews eg Standard Operating Procedures (SOP) and Policy reviews.
• Any other duty as may be assigned by the management.

Qualifications

Required Qualifications:

Education:

• Bachelor of Science in Pharmaceutical Sciences, Chemistry, Biochemistry, or related field.

Experience:

• 3 years or more of hands-on experience in regulatory affairs.

Skills and Competencies:

• Familiarity with Good Manufacturing Practice (GMP), Common Technical Document (CTD) formats, and local/international health products and technologies guidelines.
• Analytical & Organizational Skills - Strong problem-solving skills and meticulous attention to detail.
• Report writing; - strong report writing and reviewing skills.
• Cross-Functional Collaboration & Training - Effective communication skills and ability to train teams.