Remote Regulatory Affairs Specialist

Our client is seeking a highly competent and strategic Remote Regulatory Affairs Specialist to join their dynamic team, supporting operations from anywhere within South Africa, ideally coordinating with their Paarl
-based operations. This role is integral to ensuring that our client's pharmaceutical products meet all necessary regulatory requirements for approval and marketing in various global markets. You will manage regulatory submissions, liaise with health authorities, and provide expert guidance on regulatory strategies. This fully remote position is perfect for an experienced regulatory professional who thrives in an independent work environment and possesses a thorough understanding of international pharmaceutical regulations.

• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities worldwide.
• Interpret and apply relevant regulatory guidelines and legislation to product development and registration strategies.
• Serve as the primary point of contact for health authorities regarding regulatory submissions and inquiries.
• Monitor changes in the regulatory landscape and assess their impact on company products and operations.
• Collaborate with R&D, quality assurance, and commercial teams to ensure regulatory compliance throughout the product lifecycle.
• Maintain regulatory documentation and databases, ensuring all records are accurate and up-to-date.

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field; advanced degree preferred.
• Minimum of 5 years of progressive experience in Pharmaceutical Regulatory Affairs.
• Demonstrated experience in preparing and submitting marketing authorization applications in major markets (e.g., FDA, EMA, SAHPRA).
• Thorough knowledge of ICH guidelines, GxP requirements, and global regulatory submission processes.
• Excellent analytical, problem-solving, and strategic thinking skills.
• Exceptional written and verbal communication skills, with the ability to negotiate and influence effectively.

• Competitive annual salary and performance-related bonuses.
• Comprehensive medical coverage and retirement benefits.
• Flexible working hours and the freedom to work remotely.
• Professional development opportunities, including regulatory affairs training and certifications.
• A collaborative and supportive team environment, fostering continuous learning and career progression.