Pharmaceutical Regulatory Affairs Specialist

Placements24; Paarl; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive health benefits

Retirement plan

Professional growth and training

Generous annual leave

Performance-based bonus potential

Job summary

Placements24 is seeking a Pharmaceutical Regulatory Affairs Specialist in Paarl, Western Cape. You will drive regulatory submissions, liaise with SAHPRA, and monitor evolving regulations to ensure lifecycle compliance of products.

Strong collaboration with R&D, Manufacturing and QA is required. The role demands a Pharmacy, Chemistry or Life Sciences background, 3–5 years in regulatory affairs, and experience with CTD dossiers and global markets.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences or related field.
• Master's degree or equivalent advantageous.
• Minimum 3–5 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of SAHPRA requirements and global regulatory guidelines.

Responsibilities

• Prepare, review, and submit regulatory submissions (CTD, variations, renewals) to SAHPRA and other markets.
• Ensure documentation meets current regulatory guidelines and standards.
• Liaise with regulatory agencies to respond to queries and drive approvals.
• Monitor regulatory changes and advise stakeholders accordingly.
• Collaborate with R&D, Manufacturing, QA and Marketing to meet regulatory requirements.
• Maintain regulatory databases and post-marketing activities including reporting.

Skills

Regulatory affairs

Dossier preparation

Stakeholder communication

Project management

Regulatory intelligence

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences or related field

Master's degree or equivalent

Tools

Regulatory information management systems

Microsoft Office Suite

Job description

About the Role

Our client, a rapidly expanding pharmaceutical company, is seeking a dedicated and experienced Pharmaceutical Regulatory Affairs Specialist to join their team in Paarl, Western Cape. This vital role will focus on ensuring compliance with national and international regulatory requirements for pharmaceutical products throughout their lifecycle. The successful candidate will play a crucial part in preparing and submitting regulatory dossiers, liaising with health authorities, and staying ahead of evolving regulatory landscapes. This is an excellent opportunity to contribute to a company committed to developing life-saving medicines and upholding the highest standards of quality and compliance in the pharmaceutical sector.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., CTD dossiers, variations, renewals) to health authorities in South Africa and other target markets.
• Ensure all regulatory documentation meets current guidelines and standards, including those set by SAHPRA and other relevant bodies.
• Liaise with regulatory agencies to respond to queries and facilitate the approval process for new and existing products.
• Monitor and interpret regulatory changes, assess their impact on the company's products and operations, and advise stakeholders accordingly.
• Collaborate with internal departments (e.g., R&D, Manufacturing, Quality Assurance, Marketing) to ensure regulatory requirements are met throughout product development and commercialization.
• Maintain regulatory databases and ensure compliance with record-keeping requirements.
• Support post-marketing regulatory activities, including adverse event reporting and label updates.
• Contribute to the development and implementation of regulatory strategies for new product registrations and lifecycle management.
• Conduct regulatory intelligence activities to identify emerging trends and potential risks or opportunities.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• A Master's degree or equivalent is advantageous.
• Minimum of 3-5 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of pharmaceutical regulations and guidelines applicable in South Africa (SAHPRA) and ideally other key markets (e.g., FDA, EMA).
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Strong understanding of pharmaceutical product development, manufacturing, and quality systems.
• Excellent written and verbal communication skills, with a keen eye for detail.
• Ability to manage multiple projects simultaneously and meet tight deadlines.
• Strong analytical and problem-solving skills.
• Proficiency in regulatory information management systems and standard office software.

Benefits

• Competitive salary commensurate with experience and qualifications.
• Comprehensive health and retirement benefits package.
• Opportunities for professional growth and advanced training in regulatory affairs.
• A dynamic work environment within a growing pharmaceutical company.
• Generous annual leave and paid public holidays.
• Potential for performance-based bonuses.
• Supportive team culture focused on compliance and innovation.