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 key member of the team, 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.
- Oversee the implementation and maintenance of QMS to ensure compliance with industry standards and regulations.
- Identify areas for improvement within the quality system and implement corrective and preventive actions.
- Provide training to staff on quality standards, regulatory requirements, and best practices.
Requirements
- Bachelor of Pharmacy (B. Pharm)
- Registration with the South African Pharmacy Council (SAPC)
- Minimum 10 years experience in Regulatory Affairs with human medicine and biologicals experience
Qualifications
(No qualifications mentioned in the original job description)
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.
This information provides general career guidance. Actual salaries and requirements vary by employer.
GO APPLY NOW
Safe & secure application process
Explore More Opportunities
Get Similar Job Alerts
Job Seeker Tip
Always arrive 10-15 minutes early for interviews to show punctuality and reliability.
How to Apply
Click “GO APPLY NOW” to visit the company’s application page.
Follow their instructions carefully.
JVR Jobs connects you with employers – we don’t process applications directly.
Latest Job Opportunities
Gauteng: Project Manager posted by Network Finance
Our client is a large, established organisation seeking a Project Manager (PMO) to oversee and coordinate multiple projects within a…
View JobWestern Cape: Junior Graphic Designer posted by Craven Cottage CC
Duties: Assist in the creation of digital and print design materials (social media graphics, brochures, flyers, presentations, banners, etc.)Support senior...
View JobGauteng: Solutions Specialist – Gauteng posted by Bidvest Protea Coin
Research & Development (R&D)Drive innovation by identifying, testing, and integrating new security and technology solutions that enhance service delivery...
View JobSouth Africa: Airfreight Manager posted by MECS Africa
Main goalManage airfreight operations for Port Moresby branch as well as customer relationships in compliance with PNG legal requirements, Company…
View JobGauteng: Health, Safety & Environmental Officer posted by Phakisa Holdings
Purpose of the RoleTo ensure compliance with health, safety, and environmental legislation, standards, and company policies within the gold processing...
View JobPretoria North: Workshop Foreman posted by GAP Consulting
Minimum Requirements:Must have a minimum of 3-5 years’ experience as a Workshop Foreman or Senior Mechanic in the Transport &…
View Job
Browse Employers
Job Alerts