Job Description

Job purpose:

To ensure that all pharmaceutical products comply with relevant regulatory requirements and legislation, while leveraging manufacturing expertise to support product development, quality, and compliance processes. This role is critical in bridging regulatory requirements with manufacturing operations to ensure timely product registration, licensing, and quality assurance.

Key responsibilities:

r egulatory affairs

Prepare, compile, and submit regulatory dossiers (e.g. SAHPRA, WHO, FDA, EMA) for product registration and variation applications.



Ensure timely and accurate submission of documentation for product renewals, amendments, and new applications.



Maintain up-to-date knowledge of local and international regulatory guidelines and communicate changes to relevant teams.



Respond to regulatory queries and deficiency letters in a professional and timely manner.



Review and approve product labelling, packaging materials, and promotional material for compliance.



Liaise with health authorities and industry stakeholders regarding regulatory matters.

Manufacturing compliance support:

Collaborate with production, QA/QC, and R&D teams to ensure manufacturing processes meet regulatory standards.



Participate in validation, technology transfer, and scale-up processes from a regulatory standpoint.



Provide input on GMP audits and inspection readiness activities.



Support the preparation and review of batch manufacturing records and product technical files.



Assist in resolving regulatory issues affecting the manufacturing and release of products.

Qualifications and experience:

Bachelor's degree in Pharmacy (BPharm) - e ssential



Registered with the South African Pharmacy Council (SAPC) - e ssential



Minimum of 3-5 years experience in regulatory affairs - e ssential



Solid experience in pharmaceutical manufacturing environment - e ssential



Experience with SAHPRA submissions and/or global regulatory bodies - p referred

Key competencies:

Strong understanding of pharmaceutical regulations and GMP standards.



Detail-oriented with strong organisational and analytical skills.



Excellent written and verbal communication.



Ability to work cross-functionally with technical and regulatory teams.



Proficiency in MS Office and regulatory software/systems.

Additional requirements:

Ability to manage multiple projects and meet deadlines.



Flexibility to adapt to changing regulatory requirements.



Commitment to continuous professional development and learning.