Senior Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client is seeking an experienced Senior Regulatory Affairs Specialist to lead and manage regulatory submissions and strategies for pharmaceutical products in the Port Elizabeth region. This role is essential for ensuring timely approval and market access for new and existing drug products by navigating complex global regulatory landscapes. You will work closely with R&D, quality, and commercial teams to develop robust regulatory plans and prepare high-quality submission dossiers.

The ideal candidate is a seasoned regulatory professional with a deep understanding of pharmaceutical regulations and a proven ability to influence regulatory outcomes.

• Develop and implement regulatory strategies for product registration and lifecycle management in various markets.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities globally, including SAHPRA.
• Liaise with regulatory agencies, respond to queries, and manage the submission process from initiation to approval.
• Ensure compliance with all applicable regulations, guidelines, and company policies related to pharmaceutical products.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Stay abreast of evolving regulatory requirements and communicate relevant changes to internal stakeholders.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 6 years of experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals in major markets.
• In-depth knowledge of global regulatory guidelines and submission requirements for pharmaceuticals.
• Strong analytical, problem-solving, and project management skills.
• Excellent written and verbal communication skills, essential for interactions with regulatory bodies and internal teams in Port Elizabeth

• Highly competitive salary package and annual bonus.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and opportunities for remote work flexibility.
• Professional development opportunities, including regulatory affairs training and conferences.
• A challenging and rewarding career in a dynamic global pharmaceutical company.