Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client is seeking a highly organized and knowledgeable Regulatory Affairs Specialist to join their team, supporting operations from Richards Bay . This role is critical in ensuring that all pharmaceutical products meet the necessary regulatory requirements for marketing and distribution in various target markets. You will be responsible for preparing, reviewing, and submitting regulatory dossiers, maintaining compliance, and liaising with health authorities.

This position offers the chance to contribute to global health initiatives by facilitating the approval and accessibility of essential medicines, working within a flexible and forward-thinking company culture.

• Prepare and compile high-quality regulatory submission dossiers (e.g., CTD, eCTD) for new drug applications, variations, and renewals.
• Review and approve labeling, packaging, and promotional materials to ensure regulatory compliance.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
• Liaise effectively with national and international health authorities (e.g., SAHPRA) to facilitate the regulatory approval process.
• Manage post-approval regulatory activities, including annual reports and change controls.
• Provide regulatory guidance and support to internal departments, including R&D, manufacturing, and marketing.

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Proven experience in pharmaceutical Regulatory Affairs , including hands-on experience with dossier preparation and submission.
• Thorough understanding of pharmaceutical regulations and guidelines applicable in South Africa and key international markets.
• Experience with regulatory submission software and databases.
• Excellent written and verbal communication skills, with a keen eye for detail.
• Ability to manage multiple projects simultaneously and meet tight deadlines.

• Competitive annual salary with potential for merit increases.
• Comprehensive medical and retirement benefits package.
• Flexible working arrangements, including the option for remote work.
• Opportunities to work on diverse and innovative pharmaceutical products.
• Professional development support and training on regulatory updates.
• A dynamic and supportive team environment contributing to global health solutions from Richards Bay .