Regulatory Affairs Specialist - Pharmaceuticals

Placements24; Centurion; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Health benefits

Paid leave

Professional development

Performance incentives

Job summary

Placements24 seeks a Regulatory Affairs Specialist to support operations in Centurion. You will ensure pharmaceutical products meet national and international regulatory requirements, and lead submissions for new drug applications and variations.

You will liaise with regulatory authorities, guide regulatory strategy, and ensure compliance across product development and lifecycle management in a fast-paced environment.

Qualifications

• Bachelor's degree in Pharmacy, Science, or related field.
• Master's degree preferred.
• Minimum 4 years of regulatory affairs experience in pharmaceutical industry.
• Knowledge of SAHPRA and ICH guidelines.
• Experience in preparing and submitting marketing authorization applications.
• Strong written and verbal communication skills.

Responsibilities

• Prepare, review, and submit regulatory dossiers and applications to health authorities (SAHPRA).
• Monitor regulatory changes and ensure internal processes are updated.
• Liaise with regulatory agencies and manage post-approval changes.
• Develop regulatory strategies for product registration and lifecycle management.
• Review labeling to ensure regulatory compliance.
• Collaborate with R&D, manufacturing, and marketing for regulatory input.

Job description

About the Role

Our client is seeking a highly knowledgeable Regulatory Affairs Specialist to join their team, supporting operations in Centurion . In this critical role, you will be responsible for ensuring that all pharmaceutical products comply with national and international regulatory requirements, facilitating the smooth submission and approval of new drug applications and variations. You will serve as a key liaison between the company and regulatory authorities, providing expert guidance on regulatory strategy and compliance. This position is ideal for a professional who is passionate about navigating complex regulatory landscapes and contributing to bringing essential medicines to patients.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers and applications to health authorities (e.g., SAHPRA).
• Maintain regulatory compliance by monitoring changes in legislation and guidelines and ensuring internal processes are updated accordingly.
• Liaise with regulatory agencies, respond to queries, and manage post-approval changes and commitments.
• Develop and implement regulatory strategies for product registration and lifecycle management.
• Review promotional materials and product labeling to ensure compliance with regulatory standards.
• Collaborate with R&D, manufacturing, and marketing teams to provide regulatory input throughout product development and commercialization.

Requirements

• Bachelor's degree in Pharmacy, Science, or a related field; Master's degree preferred.
• Minimum of 4 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of South African pharmaceutical regulations (SAHPRA) and international guidelines (e.g., ICH).
• Proven experience in preparing and submitting marketing authorization applications.
• Excellent written and verbal communication skills, with a strong command of regulatory documentation.
• Ability to manage multiple projects simultaneously and work effectively under tight deadlines in Centurion.

Benefits

• Competitive annual salary and potential for performance incentives.
• Comprehensive health and wellness benefits package.
• Generous vacation and leave policies.
• Support for continuous professional development and regulatory training.
• A dynamic work environment with opportunities to influence regulatory strategy.