Senior Regulatory Affairs Specialist - Pharmaceuticals

Our client, a dynamic player in the Pharmaceutical sector, is seeking a meticulous and experienced Senior Regulatory Affairs Specialist to join their team in Cape Town, Western Cape, ZA . This role is pivotal in ensuring that our client's products comply with all relevant national and international regulatory requirements, facilitating timely product approvals and market access. The position involves preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulatory landscapes.

This role adopts a hybrid work model, blending remote work with essential on-site collaboration at our Cape Town office. The ideal candidate has a comprehensive understanding of pharmaceutical regulations and a proven ability to navigate complex submission processes. You will be a key contributor to our client's success by ensuring adherence to the highest standards of regulatory compliance within the Pharmaceutical industry.

Your expertise will be crucial in bringing innovative treatments to patients efficiently and safely.

• Prepare, review, and submit regulatory dossiers for new drug applications (NDAs), variations, and renewals.
• Liaise with regulatory authorities such as SAHPRA, FDA, EMA, and others as required.
• Interpret and communicate regulatory requirements and guidelines to internal teams.
• Develop regulatory strategies to support product development and lifecycle management.
• Maintain regulatory compliance by monitoring changes in regulations and guidelines.
• Provide regulatory input and support for product labeling, advertising, and promotional materials.
• Conduct regulatory intelligence gathering and competitor analysis.
• Participate in regulatory inspections and respond to authority queries.
• Collaborate with cross-functional teams including R&D, Clinical Affairs, Marketing, and Manufacturing.
• Ensure timely and accurate updates to regulatory databases and documentation.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Minimum of 6 years of experience in Regulatory Affairs within the Pharmaceutical industry.
• Thorough understanding of global pharmaceutical regulatory requirements and submission processes (e.g., CTD format).
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Excellent analytical, organizational, and problem-solving skills.
• Strong written and verbal communication skills, with keen attention to detail.
• Ability to work independently and manage multiple projects in a deadline-driven environment.
• Experience with hybrid work arrangements is preferred.
• Familiarity with the South African regulatory landscape (SAHPRA) is advantageous.
• Based in or willing to relocate to the Cape Town area.

• Competitive annual salary of ZAR.
• Hybrid work flexibility.
• Comprehensive medical insurance coverage.
• Retirement fund benefits.
• Opportunities for professional development and international training.
• Annual bonus potential based on performance.
• Stimulating work environment within a growing Pharmaceutical company.
• Paid vacation and public holidays.
• Contribution to healthcare initiatives.
• Access to industry conferences and networking events.