Regulatory Affairs Manager

1 month ago


Johannesburg, South Africa Jobted ZA C2 Full time

Minimum Requirements

- Matric
- Pharm (Bachelor of Pharmacy)
- South African Pharmacy Council (SAPC) registration
- Valid Drivers License and Own vehicle
- 5 10 years experience in Regulatory Affairs
- Must have management experience
- Responsible for ensuring a thorough and seamless product registration process and dossier maintenance
- Responsible for the Southern and Eastern Africa Region
- Lead, manage, and execute strategic direction
- 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



  • Johannesburg, South Africa PSM Personnel Full time

    Regulatory Affairs Manager Pharmacist ~ Regulatory Johannesburg North-Gauteng Qualifications and Experience - Bachelors degree in Pharmacy/Diploma in Pharmacy - Registration with the South African Pharmacy Council - Minimum of 5 years experience in Regulatory Affairs, preferably in human medicines - Demonstrable experience across the product development,...


  • Johannesburg, Gauteng, South Africa Curiska Full time

    Regulatory Affairs ManagerCuriska is seeking a highly skilled Regulatory Affairs Manager to oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.Key Responsibilities:Develop and implement regulatory strategies and documentation.Ensure compliance with regulatory...


  • Johannesburg, Gauteng, South Africa Curiska (Pty) Ltd Full time

    Regulatory Affairs ManagerCuriska (Pty) Ltd is seeking a highly skilled Regulatory Affairs Manager to oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.Key Responsibilities:Develop and implement regulatory strategies and documentation.Ensure compliance with...


  • Johannesburg, South Africa Curiska Full time

    Hiring: Regulatory Affairs Manager Location: Midrand, South Africa   As a Regulatory Affairs Manager, you will oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.   Key Responsibilities Regulatory Strategy: Lead and manage regulatory strategies and documentation....


  • Johannesburg, South Africa Curiska Full time

    Hiring: Regulatory Affairs ManagerLocation: Midrand, South Africa As a Regulatory Affairs Manager, you will oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements. Key ResponsibilitiesRegulatory Strategy: Lead and manage regulatory strategies and...


  • Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72786 **Job Type** - Permanent **Job Title** - Regulatory Affairs Manager **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng **Reporting to Head: Regulatory Affairs** **Job purpose**: - Support the Regulatory team to provide superior Regulatory services...


  • Johannesburg, South Africa Curiska (Pty) Ltd Full time

    Hiring: Regulatory Affairs ManagerLocation: Midrand, South Africa As a Regulatory Affairs Manager, you will oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements. Key ResponsibilitiesRegulatory Strategy: Lead and manage regulatory strategies and...


  • Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 71064 **Job Type** - Permanent **Job Title** - Regulatory Affairs Pharmacist **Computer Skills** - Adobe Acrobat,MS Excel **Industry** - Manufacture **City** - Johannesburg **Province** - Gauteng - Reporting to RA Systems Manager**Job purpose** - Maintain applicable regulatory affairs information management electronic systems, ensuring...


  • Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72989 **Job Type** - Permanent **Job Title** - Regulatory Affairs Pharmacist **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng - Reporting To Regulatory Affairs Manager / Senior RA Pharmacist**Job Purpose** - To Support the Regulatory Affairs team with...


  • Johannesburg, Gauteng, South Africa The Vine Partners Full time

    Job Title: Regulatory Affairs PharmacistLocation: Johannesburg, GautengSalary: R62,000 - R67,000 per monthAbout the Role:We are seeking a skilled Regulatory Affairs Pharmacist to manage the regulatory aspects of our product portfolio, ensuring compliance with regulatory standards and overseeing submissions to regulatory authorities like SAHPRA and other...


  • Johannesburg South, South Africa Emporium Full time

    Lead Regulatory Affairs ProfessionalAt Emporium, we are committed to excellence in regulatory affairs.The position of Regulatory Affairs Manager is available for a highly skilled professional with expertise in regulatory compliance and team leadership. The role involves leading the Regulatory team to deliver superior services to relevant departments within...


  • Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 71851 **Job Type** - Permanent **Job Title** - Head of Regulatory Affairs **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng **Reporting To Managing Director - company OTC** **Job Purpose** - The Head of Regulatory Affairs holds ultimate responsibility...


  • Johannesburg, South Africa Jalusi Corporation Full time

    **Job Summary**: The Regulatory Affairs Specialist will be responsible for ensuring that the company's products comply with all relevant regulations and standards. This role involves preparing and submitting documentation to regulatory agencies, maintaining compliance, and staying updated on regulatory changes. **Key Responsibilities**: - **Regulatory...


  • Johannesburg South, South Africa Emporium Human Capital Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:Emporium Human Capital is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for providing superior Regulatory services to relevant departments within the company and with external partners and Principals.Key...


  • Johannesburg, South Africa PSM Personnel Full time

    Head of Regulatory Affairs Pharmacist ~ Regulatory Johannesburg North-Gauteng We are looking for the Head of Regulatory Affairs to join our clients team of experts, a leader who has managed people for a minimum of 5 years. Someone who will oversee the development and delivery of a fully integrated regulatory strategy for the business. In this role, you...


  • Johannesburg South, South Africa Emporium Human Capital Full time

    Job Title: Regulatory Affairs PharmacistAbout the Role:We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for human medicines, including complementary medicines and medical devices.Key...


  • Johannesburg, South Africa The Vine Partners Full time

    Job Title: Regulatory Affairs PharmacistLocation: Johannesburg, GautengSalary: R62,000 - R67,000 per monthAbout the Role:We are seeking a skilled and detail-oriented Regulatory Affairs Pharmacist to join our client's team. The successful candidate will be responsible for managing the regulatory aspects of our product portfolio, ensuring compliance with...


  • Johannesburg, South Africa Johnson & Johnson Full time

    **REGULATORY AFFAIRS PHARMACIST** **Location: Gauteng** **Contract: Permanent** **The responsibilities & the impact YOU will have**: **Summary** To effectively complete all required Regulatory tasks relating to product registrations and dossier lifecycle maintenance for products the local operating company (LOC) has regulatory responsibility and to...


  • Johannesburg, Gauteng, South Africa Curiska Full time

    Regulatory Affairs Manager Position at CuriskaWe are seeking a highly skilled Regulatory Affairs Manager to oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.Key ResponsibilitiesRegulatory Strategy: Develop and implement regulatory strategies and...


  • Johannesburg South, South Africa Emporium Full time

    Job Title: Regulatory Affairs PharmacistEmporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and maintaining effective relationships with regulatory authorities.Key Responsibilities:Manage work streams...