Job Description

Regulatory Affairs Operations Lead AI OTC Operations ~ Regulatory
Gauteng - South Africa
Our client in the pharmaceutical industry is seeking a Regulatory Affairs Operations Lead to oversee regulatory operations activities and strategic initiatives supporting both pre- and post-approval submissions. This role is ideal for a detail-oriented professional with advanced regulatory systems knowledge and a passion for driving process improvement within a compliance-driven environment.
Your Responsibilities:

• Oversee and guide teams managing the creation, assembly, and publishing of electronic submissions, including new product applications and lifecycle amendments.
• Represent Regulatory Operations on project teams, ensuring submission timelines and deliverables are met.
• Maintain up-to-date knowledge of regulatory requirements, ICH guidelines, and internal processes governing electronic documentation.
• Collaborate with cross-functional teams (clinical, quality, regulatory) to ensure documents comply with health authority and company standards.
• Lead the development and implementation of internal procedures, work instructions, and training programs within the Regulatory Affairs Systems department.
• Support the introduction of new technology solutions for document preparation, management, and submission.
• Provide training, guidance, and leadership to regulatory personnel and project teams.
• Ensure alignment of personal and company values, promoting excellence, integrity, and collaboration.

Minimum Requirements:

• Bachelors degree in Pharmacy, Life Sciences, or Technology-related discipline, with at least 2 years of regulatory operations experience
• Expertise in eCTD publishing systems, electronic document management, and lifecycle management processes.
• Proven ability to manage projects, timelines, and cross-functional collaboration.
• Experience developing SOPs and work instructions aligned with health authority requirements.
• Strong technical proficiency in Microsoft Office, Adobe Acrobat, and document management tools.
• Excellent communication, problem-solving, and leadership skills.

We are looking for a proactive, collaborative professional with a deep understanding of electronic submission systems and a commitment to quality and regulatory compliance. Someone who is an experienced regulatory professional with a strong technical background in electronic submissions and document management systems.
If you are ready to lead a high-performing team in a dynamic pharmaceutical environment, please apply.
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