Senior Regulatory Affairs Specialist - Pharmaceutical

Placements24; Pretoria; On-site; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Medical aid

Provident fund

Paid time off

Professional development

International training

On-site parking

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and lifecycle management for pharmaceutical products in Pretoria, Gauteng. The role requires on-site presence to liaise with SAHPRA and other authorities, ensuring compliance and timely market authorization.

The ideal candidate will bring 5+ years of SA regulatory affairs experience, strong strategic thinking, and excellent communication skills to guide project teams through global regulatory

Qualifications

• 5+ years of regulatory affairs experience in the pharmaceutical industry.
• Experience with SAHPRA submissions and lifecycle management.
• Understanding of SA regulatory landscape and international requirements (FDA/EMA) is advantageous.
• Excellent organizational and project management skills.

Responsibilities

• Prepare, review, and submit regulatory dossiers to SAHPRA and other authorities.
• Manage lifecycle of registered products, incl. post-approval changes and renewals.
• Provide strategic regulatory advice to project teams.
• Serve as primary contact for regulatory agencies and respond to queries.
• Monitor evolving regulatory requirements and guidelines.
• Assess regulatory impact of changes to labeling and manufacturing.
• Collaborate with R&D, QA, Marketing and other departments.
• Maintain regulatory records and documentation systems.
• Support regulatory intelligence activities and track trends.
• Participate in regulator meetings and inspections.

Skills

Regulatory affairs

Lifecycle management

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Education

Bachelor's degree in Pharmacy/ Chemistry/ Life Sciences

Master's degree preferred

Tools

Regulatory information management systems

Job description

About the Role

Our client, a dynamic pharmaceutical company, is actively seeking a highly skilled Senior Regulatory Affairs Specialist to join their team in Pretoria, Gauteng, ZA . This role is pivotal in ensuring that our client's pharmaceutical products meet all necessary regulatory requirements for marketing authorization and lifecycle management. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and providing strategic regulatory guidance across various stages of product development. The ideal candidate will have a deep understanding of the South African regulatory landscape and experience with international submissions. This is an excellent opportunity to contribute to bringing essential medicines to patients while working within a collaborative and growth-oriented environment. The position requires on-site presence to facilitate necessary interactions and regulatory processes.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTX, NDA, variations) to the South African Health Products Regulatory Authority (SAHPRA) and other relevant health authorities.
• Manage the lifecycle of registered products, including post-approval changes and renewals.
• Provide strategic regulatory advice to project teams, ensuring compliance throughout product development.
• Serve as the primary point of contact for regulatory agencies, responding to queries and addressing deficiencies.
• Monitor and interpret evolving regulatory requirements and guidelines.
• Assess the regulatory impact of proposed changes to product labeling, manufacturing processes, and clinical trial protocols.
• Collaborate with R&D, Quality Assurance, Marketing, and other departments to ensure alignment on regulatory strategies.
• Maintain regulatory compliance records and documentation systems.
• Support regulatory intelligence activities by tracking regulatory trends and competitor activities.
• Participate in regulatory authority meetings and inspections.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field; Master's degree preferred.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry, with a strong focus on the South African market.
• Proven experience in preparing and submitting successful regulatory dossiers to SAHPRA.
• Comprehensive understanding of South African pharmaceutical regulations and guidelines.
• Familiarity with international regulatory requirements (e.g., FDA, EMA) is advantageous.
• Excellent organizational and project management skills.
• Strong analytical and problem-solving capabilities.
• Exceptional communication and interpersonal skills, with the ability to negotiate effectively.
• Proficiency in regulatory information management systems.
• Must be willing to work full-time on-site in Pretoria, Gauteng, ZA .

Benefits

• Annual salary of R .
• Comprehensive medical aid and provident fund.
• Paid time off and public holidays.
• Opportunities for professional development and international training.
• Exposure to diverse pharmaceutical portfolios.
• Collaborative team environment.
• On-site parking and other facility benefits.