Regulatory Affairs Specialist

1 day ago


Midrand, Gauteng, South Africa Hire Resolve Full time
Regulatory Affairs Manager Job Description

Hire Resolve's client is seeking a highly skilled Regulatory Affairs Manager to join their team in Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring a seamless product registration process and dossier maintenance.

Key Responsibilities:
  • Lead and manage the regulatory affairs function to ensure compliance with all regulations and pharmacovigilance requirements.
  • Develop and implement strategic direction for regulatory affairs, ensuring alignment with business objectives.
  • Manage and execute regulatory documentation, including SOPs, work instructions, and quality records.
  • Provide input to the regulatory strategy and ensure compliance with industry standards and regulations.
  • Manage product complaints and deviations, and maintain regulatory documentation filing systems.
  • 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 ADRs to Global Safety and SAHPRA, and follow up on Adverse Drug Reactions.
Requirements:
  • B. Pharm (Bachelor of Pharmacy) degree.
  • Registration with the South African Pharmacy Council (SAPC).
  • Minimum 10 years of experience in Regulatory Affairs with human medicine and biologicals experience.
  • Product registration and dossier maintenance experience.
  • 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.


  • Midrand, Gauteng, South Africa The Globevest Group Full time

    Regulatory Affairs Manager Job DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at The Globevest Group. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and maintaining a seamless product registration process.Main Responsibilities:Lead the development and...


  • Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Title: Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.About the RoleWe are looking for a seasoned professional with expertise in regulatory affairs, particularly in human medicines, including complementary medicines and medical devices. The successful candidate will be...


  • Midrand, Gauteng, South Africa Globevest Group Full time

    Regulatory Affairs ManagerCompany Overview:Globevest Group is an international pharmaceutical company with a strong presence in Midrand. We are seeking a highly skilled Regulatory Affairs Manager to join our team.Job Summary:The Regulatory Affairs Manager will be responsible for ensuring compliance with all regulations and maintaining the company's...


  • Midrand, Gauteng, South Africa Emporium Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.Key ResponsibilitiesRegulatory ComplianceManage work streams for- and report on the...


  • Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Title: Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.Key Responsibilities:Manage work streams for- and report on the assigned portfolio of products, ensuring timely and accurate submissions to regulatory agencies.Establish regulatory priorities and allocate resources and...


  • Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.Key Responsibilities:Develop and implement regulatory strategies for human medicines, including complementary medicines and medical devices.Manage end-to-end regulatory activities, ensuring compliance with Good Manufacturing...


  • Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Title: Regulatory Affairs PharmacistEmporium Human Capital 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 guidelines for pharmaceutical products.Key Responsibilities:Manage work streams for- and...


  • Midrand, Gauteng, South Africa The Globevest Group Full time

    Regulatory Affairs ManagerOur client, a leading international pharmaceutical company, is seeking a highly skilled Regulatory Affairs Manager to join their team in Midrand. As a key member of the team, you will be responsible for ensuring compliance with all regulations and maintaining the company's pharmacovigilance requirements.Main Responsibilities:Lead...


  • Midrand, Gauteng, South Africa Emporium Full time

    Senior Regulatory Affairs Pharmacist: Pain, Derma & Digestive (PDD)Emporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team in Midrand. As a key member of our regulatory affairs team, you will be responsible for managing work streams for- and reporting on the assigned portfolio of products.Key Responsibilities:Manage...


  • Midrand, Gauteng, South Africa Emporium Full time

    Senior Regulatory Affairs Pharmacist: Pain, Derma & Digestive (PDD)Emporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team in Midrand. As a key member of our regulatory affairs team, you will be responsible for managing work streams and reporting on assigned portfolios of products.Key Responsibilities:Manage internal...


  • Midrand, Gauteng, South Africa The Globevest Group Full time

    Regulatory Affairs ManagerOur client, a leading international pharmaceutical company, is seeking a highly skilled Regulatory Affairs Manager to join their team in Midrand. As a key member of the team, you will be responsible for ensuring compliance with all regulations and maintaining the company's pharmacovigilance requirements.Main Responsibilities:Lead...


  • Midrand, Gauteng, South Africa Emporium Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.Key ResponsibilitiesManage work streams for- and report on the assigned portfolio of...


  • Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Senior Regulatory Affairs Pharmacist: Pain, Derma & Digestive (PDD)Emporium Human Capital is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team in Midrand. As a key member of our regulatory affairs team, you will be responsible for managing work streams and reporting on assigned portfolios of products.Key Responsibilities:Manage...


  • Midrand, Gauteng, South Africa The Globevest Group Full time

    Regulatory Affairs Manager Job DescriptionOur client, an international pharmaceutical company, is seeking a highly skilled Regulatory Affairs Manager to join their team in Midrand. The successful candidate will be responsible for ensuring compliance with all regulations and maintaining the company's pharmacovigilance requirements.Main Responsibilities:Lead...


  • Midrand, Gauteng, South Africa The Globevest Group Full time

    Regulatory Affairs Manager Job DescriptionJob Title: Regulatory Affairs ManagerCompany: The Globevest GroupLocation: MidrandJob Type: PermanentIndustry: PharmaceuticalJob Reference: RDT.S.RAMJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team in Midrand. The successful candidate will be responsible for ensuring compliance...


  • Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. The successful candidate will be responsible for managing work streams, reporting on assigned portfolios of products, and ensuring regulatory compliance.Key ResponsibilitiesManage work streams for- and report on the assigned portfolio of...


  • Midrand, Gauteng, South Africa The Globevest Group Full time

    Regulatory Affairs Manager Job DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at The Globevest Group. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and maintaining our company's pharmacovigilance standards.Main Responsibilities:Lead the development and...


  • Midrand, Gauteng, South Africa Hire Resolve Full time

    Job Title: Regulatory Affairs ManagerHire Resolve's client is seeking a highly skilled Regulatory Affairs Manager to join their team in Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring a seamless product registration process and dossier maintenance. You will ensure that the company complies with all regulations and maintains...


  • Midrand, Gauteng, South Africa Jordan HR Full time

    Jordan HR is seeking a highly skilled and experienced professional to fill the role of Head of Regulatory Affairs Manager. The ideal candidate will possess a strong background in pharmaceutical regulatory affairs and have a proven track record of leading cross-functional teams to drive collaboration, innovation, and operational excellence. Key...


  • Midrand, Gauteng, South Africa The Globevest Group Full time

    Job Title: Regulatory Affairs ManagerJob Type: PermanentIndustry: PharmaceuticalLocation: MidrandJob Description:Key Responsibilities:Lead Regulatory Affairs: Develop and implement regulatory strategies to ensure compliance with relevant laws and regulations.Product Registration: Oversee the registration process for new products, ensuring all necessary...