Regulatory Affairs Specialist

Placements24; Rustenburg; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Pension plan

Profit sharing

Generous leave

Training programs

Job summary

Placements24 is seeking an experienced Regulatory Affairs Specialist in Rustenburg to ensure compliance with SAHPRA and international guidelines. You will prepare dossiers, liaise with health authorities, and guide cross-functional teams on regulatory requirements across product lifecycles.

The role requires a life sciences degree and 4+ years in regulatory affairs, with strong analytical and communication skills for interactions with regulators and internal stakeholders.

Qualifications

• Bachelor’s degree in a life science field and 4+ years in pharma regulatory affairs.
• Experience preparing CTD dossiers for regulatory approvals.
• Strong knowledge of SAHPRA and international guidelines.

Responsibilities

• Prepare, review, and submit regulatory submissions to health authorities.
• Maintain regulatory compliance for products throughout their lifecycle.
• Interpret guidelines and assess impact on products and processes.
• Coordinate with R&D, QA, and Marketing to meet regulatory requirements.
• Develop regulatory strategies to support development and commercialization.

Skills

Regulatory affairs

Project management

Analytical thinking

Communication

Education

Bachelor's degree in life sciences

Job description

About the Role

Our client is seeking an experienced Regulatory Affairs Specialist to join their expanding team in Rustenburg . This role is critical for ensuring that all company products meet the complex and ever-changing regulatory requirements in South Africa and international markets. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and providing regulatory guidance to cross-functional teams. The ideal candidate will have a strong understanding of pharmaceutical regulations, excellent attention to detail, and the ability to navigate complex compliance landscapes. This is a key position that directly contributes to the company's market access and product lifecycle management, offering a chance to work in a dynamic and growth-oriented pharmaceutical company.

Key Responsibilities

• Prepare, review, and submit regulatory submissions for new product registrations, variations, and renewals to relevant health authorities.
• Maintain regulatory compliance for all assigned products throughout their lifecycle.
• Interpret regulatory guidelines and assess their impact on company products and processes.
• Serve as a primary point of contact for regulatory agencies, responding to inquiries and addressing regulatory issues.
• Collaborate with R&D, Quality Assurance, and Marketing departments to ensure regulatory requirements are met at all stages.
• Develop and implement regulatory strategies to support product development and commercialization goals.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• A minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting dossiers (e.g., CTD format) for regulatory approvals.
• In-depth knowledge of South African pharmaceutical regulations (SAHPRA) and relevant international guidelines.
• Excellent analytical, organizational, and project management skills.
• Strong interpersonal and communication skills, with the ability to effectively negotiate with regulatory bodies.

Benefits

• Highly competitive salary package with annual reviews.
• Comprehensive health, disability, and life insurance.
• Pension fund contributions and profit-sharing opportunities.
• Generous annual leave and sick leave benefits.
• Professional development and training programs to enhance regulatory expertise in Rustenburg .