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:
- Bachelor’s 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.