Midrand: Regulatory Affairs Manager posted by Hire Resolve

January 18, 2026 Jobs in Gauteng

Hire Resolve

Gauteng

Other Manufacturing

Job Description

About the Role

Hire Resolve’s client is actively seeking a Regulatory Affairs Manager to join their team in Midrand, Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring a thorough and seamless product registration process and dossier maintenance. You will ensure that the company complies with all regulations and maintains pharmacovigilance requirements.

Key Responsibilities

Lead, manage, and execute strategic direction as the regulatory affairs manager.
Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications.
Provide input to the regulatory strategy in line with business objectives.
Manage and implement safety updates where required.
Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations.
Handle license renewals with service providers such as SAHPRA and the South African Pharmacy Council (SAPC)
Write and develop SOPs in line with Global SOPs.
Manage internal and external audits (e.g., Global & SAHPRA).
Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation.
Manage product complaints and deviations.
Maintain regulatory documentation filing system.
Ensure regulatory compliance and quality-related records are available and retained.
Coordinate product recall or market withdrawal when necessary.
Obtain and distribute updated information on domestic and international laws.
Report ADR to Global Safety and SAHPRA and follow up on Adverse Drug Reactions (ADRs).
Conduct pharmacovigilance training for local staff
Answer requests from the Regulatory Authority in cooperation with Global Safety

Requirements

Registration with the South African Pharmacy Council (SAPC)
Minimum 10 years experience in Regulatory Affairs with human medicine and biologicals experience.
Product registration and dossier maintenance.
Pharmacovigilance experience and knowledge of SAHPRA submission portals.
Launch procedures for new products.
QA processes, APQRs, customer complaints.
Knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa.
Microsoft Office Suite proficiency.
Familiarity with ZAZIBONA processes and eCTD submissions
Systems knowledge.

View Job Cape Town: Audit Supervisor posted by Hire Resolve

Qualifications

B. Pharm (Bachelor of Pharmacy)

Salary & Benefits

Salary: negotiable

How to Apply

Click the green “Go Apply” button below to apply directly online with the employer.

About Other Manufacturing Jobs in Gauteng

The manufacturing sector in Gauteng, South Africa is generally a thriving industry, with many opportunities available for those looking to start or advance their careers. Typically, the job market in this field is competitive, but there are various roles and sectors to consider. Generally, the demand for skilled workers in manufacturing is high due to the growth of industries such as technology and e-commerce.

In terms of salary expectations, it’s common for manufacturing professionals in Gauteng to earn between R600 000 to R1 200 000 per annum, depending on factors such as experience, company size, and industry sector. However, please note that these are broad ranges and actual salaries can vary significantly. For example, those with specialized skills or working in larger companies may earn at the higher end of this range, while entry-level positions may start at a lower salary.

Common skills for manufacturing roles include technical knowledge, problem-solving abilities, attention to detail, leadership skills, effective communication, and adaptability. Typically, manufacturers require workers who can work efficiently, maintain high-quality standards, and collaborate with colleagues and suppliers.

Manufacturing jobs can be found in various industries such as the technology industry, financial services sector, manufacturing sector, and automotive industry, among others. These sectors often require specialized skills and training, but also offer opportunities for career advancement and professional growth.

For those looking to start or advance their careers in manufacturing, there are various opportunities available. Typically, entry-level positions can be a good starting point, with many companies offering on-the-job training and development programs. As experience is gained, workers can move into supervisory or management roles, where they can develop leadership skills and oversee production operations. With specialized skills and certifications, professionals can also transition into more technical or specialized roles, such as quality control or supply chain management.

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This information provides general career guidance. Actual salaries and requirements vary by employer.

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