Senior Regulatory Affairs Specialist - Centurion

Placements24; Centurion; Hybrid; ZAR 900,000 - 1,200,000; Full time

Job summary

Placements24 in Centurion, Gauteng seeks a Senior Regulatory Affairs Specialist to oversee compliance of pharmaceutical products with SAHPRA and international standards, manage registrations, variations and post-approval changes, and shape regulatory strategy across markets. The role requires a Bachelor’s in Pharmacy/Science/Law, 5–7 years in regulatory affairs, CTD knowledge, and strong communication.

You will collaborate with development, manufacturing and marketing teams to ensure timely

Qualifications

• Bachelor's degree in Pharmacy, Science or Law required.
• 5–7 years in regulatory affairs within pharma.
• Knowledge of SAHPRA regulations and CTD format required.
• Experience in preparing and submitting regulatory applications.

Responsibilities

• Prepare and manage regulatory dossiers for NDAs, variations and renewals per SAHPRA requirements.
• Provide regulatory guidance to product development, manufacturing and marketing teams.
• Monitor regulatory changes and assess impact on products and operations.
• Liaise with regulatory agencies and external partners on submissions and inquiries.
• Review labeling, packaging and promotional materials for compliance.
• Develop and implement regulatory policies and procedures.
• Conduct regulatory due diligence for BD activities and acquisitions.
• Maintain regulatory databases and documentation.
• Lead or participate in regulatory inspections and audits.

Skills

Regulatory affairs

SAHPRA knowledge

CTD format

Stakeholder management

Education

Bachelor's degree in Pharmacy/Science/Law

Master's degree or certification

Tools

Regulatory information systems

Job description

About the Role

Our client, a prominent player in the pharmaceutical sector, is seeking an experienced Senior Regulatory Affairs Specialist to be based in Centurion, Gauteng . This crucial role involves ensuring that all pharmaceutical products comply with national and international regulatory standards, facilitating product registration, and managing post-approval changes. The ideal candidate will possess a deep understanding of the regulatory landscape governing pharmaceuticals in South Africa and key international markets. This is an exceptional opportunity to influence regulatory strategy and contribute to market access for innovative medicines. We are looking for a proactive and detail-oriented professional who can navigate complex regulatory frameworks and collaborate effectively with various stakeholders.

Key Responsibilities

• Prepare, submit, and manage regulatory dossiers for new drug applications (NDAs), variations, and renewals in compliance with SAHPRA and other relevant health authority requirements.
• Provide regulatory guidance and strategic input to product development, manufacturing, and marketing teams.
• Monitor changes in the regulatory environment and assess their impact on the company's products and operations.
• Liaise with regulatory agencies, health authorities, and external partners on regulatory submissions and inquiries.
• Review and approve promotional materials, labeling, and packaging to ensure regulatory compliance.
• Develop and implement regulatory affairs policies and procedures.
• Conduct regulatory due diligence for potential business development activities and product acquisitions.
• Maintain regulatory databases and documentation systems.
• Lead or participate in regulatory inspections and audits.

Requirements

• A Bachelor's degree in Pharmacy, Science, Law, or a related discipline.
• A Master's degree or relevant professional certification is a plus.
• A minimum of 5-7 years of progressive experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of SAHPRA regulations, CTD format, and global regulatory submission processes.
• Proven experience in preparing and submitting various types of regulatory applications.
• Excellent understanding of pharmaceutical product lifecycle management.
• Strong analytical, problem-solving, and strategic thinking abilities.
• Exceptional written and verbal communication skills, with strong negotiation and influencing capabilities.
• Ability to manage multiple projects simultaneously and meet strict deadlines.
• Proficiency in regulatory information management systems.

Benefits

The successful candidate will be offered a competitive salary, comprehensive health and wellness benefits, and opportunities for career advancement within a growing organization. Our client provides a dynamic and collaborative work environment with a focus on professional development and continuous learning. The role is situated in Centurion, Gauteng , offering a central and accessible work location. This is a significant opportunity to make a tangible impact on regulatory strategy and contribute to bringing essential medicines to market.