Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client is seeking a knowledgeable and proactive Regulatory Affairs Specialist to support their pharmaceutical product portfolio, based in or near Mossel Bay. You will be responsible for preparing, submitting, and maintaining regulatory documentation required for product registration and compliance with health authorities. This role involves interpreting regulatory guidelines, ensuring adherence to local and international standards, and collaborating with cross-functional teams.

Some aspects of reporting and documentation review can be performed remotely, offering a hybrid work model. You will be key to ensuring our client's products reach patients safely and effectively by navigating complex regulatory landscapes.

• Prepare, compile, and submit regulatory dossiers (e.g., CTD, eCTD) for new product registrations and variations.
• Liaise with health authorities (e.g., SAHPRA) to address queries and facilitate the approval process.
• Ensure all company products comply with current local and international regulatory requirements and guidelines.
• Review and approve promotional materials, labeling, and packaging for regulatory compliance.
• Maintain regulatory databases and track submission status, approvals, and post-approval commitments.
• Provide regulatory guidance and support to internal stakeholders, including R&D, marketing, and quality assurance.

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Solid understanding of pharmaceutical regulations and submission processes in South Africa (SAHPRA) and potentially other key markets.
• Experience with eCTD compilation and submission software.
• Strong analytical, organizational, and communication skills.
• Ability to manage multiple projects simultaneously and meet strict deadlines.

• Competitive salary and performance-related bonuses.
• Comprehensive health and retirement benefits.
• Opportunities for career advancement and international exposure.
• Supportive team environment focused on regulatory excellence.
• A blend of on-site and remote work flexibility to enhance work-life integration.