Current jobs related to Regulatory Affairs Manager - Midrand, Gauteng - The Globevest Group

  • Regulatory Affairs Manager

    1 month ago

    Midrand, Gauteng, South Africa Set Consulting Full time

    Job Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Set Consulting. As a key member of our Public Policy and Regulatory Affairs team, you will be responsible for managing all regulatory and compliance developments and affairs for the company, ensuring our understanding and adherence to relevant financial regulations,...

  • Regulatory Affairs Manager

    2 months ago

    Midrand, Gauteng, South Africa SET Recruitment Consultants Full time

    At SET Recruitment Consultants, we are seeking a highly skilled Regulatory Affairs Manager to join our team. The successful candidate will be responsible for managing all regulatory and compliance developments and affairs for the company, ensuring adherence to relevant financial regulations, laws, and industry guidelines.Key Responsibilities:Ensure the...

  • Regulatory Affairs Manager

    2 months ago

    Midrand, Gauteng, South Africa CA Financial Appointments Full time

    CA Financial Appointments is seeking a Regulatory Affairs Manager to join their team in the financial services sector. This role reports directly to the Head of Public Policy and Regulatory and is responsible for managing all regulatory and compliance developments and affairs.Key Responsibilities:Ensure the company's understanding and adherence to relevant...

  • Regulatory Affairs Specialist

    1 month ago

    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. The ideal candidate will have a strong background in regulatory affairs, with experience in human medicines, including complementary medicines and medical devices.Key Responsibilities:Manage end-to-end regulatory...

  • Regulatory Affairs Director

    1 week ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job DescriptionThe Head of Regulatory Affairs is responsible for driving the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives.Key ResponsibilitiesAdopt a risk-based assessment for all regulatory submissions and formulate regulatory risk mitigation strategies as...

  • Regulatory Affairs Strategist

    1 month ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job SummaryAs a Regulatory Affairs Strategist at Emporium Human Capital, you will be responsible for driving the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives. You will adopt a risk-based assessment for all regulatory submissions and formulate regulatory risk mitigation...

  • Regulatory Affairs Director

    1 month ago

    Midrand, Gauteng, South Africa CA Financial Appointments Full time

    Regulatory Affairs DirectorCA Financial Appointments is seeking a seasoned Regulatory Affairs Director to join our team in the financial services sector. This key role reports directly to the Head of Public Policy and Regulatory, and is responsible for managing all regulatory and compliance developments and affairs.Responsibilities:Ensure the company's...

  • Regulatory Affairs Director

    4 weeks ago

    Midrand, Gauteng, South Africa SET Recruitment Consultants Full time

    Job Summary:We are seeking an experienced Regulatory Affairs Director to join our team at SET Recruitment Consultants.About the Role:The successful candidate will be responsible for managing all regulatory and compliance developments and affairs for our clients, ensuring their understanding and adherence to relevant financial regulations, laws, and industry...

  • Regulatory Affairs Director

    3 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Emporium Human Capital is seeking a highly skilled Regulatory Affairs Director to lead our OTC division's regulatory activities and develop a comprehensive regulatory strategy.The ideal candidate will have a strong background in pharmaceutical regulatory affairs, with at least 8 years of experience and a B. Pharm degree. They should be registered with...

  • Regulatory Affairs Specialist

    2 months ago

    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 pharmaceutical products, ensuring compliance with relevant laws and regulations.Collaborate with cross-functional teams to ensure regulatory requirements are met...

  • Regulatory Affairs Specialist

    2 months ago

    Midrand, Gauteng, South Africa Emporium Full time

    Regulatory Affairs Pharmacist RoleEmporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team in Midrand. 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 Responsibilities:Develop and...

  • Regulatory Affairs Director

    2 weeks ago

    Midrand, Gauteng, South Africa Jordan HR Full time

    Job OverviewJordan HR seeks a seasoned Regulatory Affairs professional to lead our team in ensuring compliance with regulatory requirements for human medicines.About the RoleThis is a challenging opportunity for an experienced Regulatory Affairs Manager to take on a leadership role, leveraging their expertise to drive quality, time, and cost standards across...

  • Regulatory Affairs Specialist

    1 month ago

    Midrand, Gauteng, South Africa Jordan HR Full time

    At Jordan HR, we are seeking a skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our pharmaceutical products with regulatory requirements.This role involves extensive experience in regulatory affairs, preferably in human medicines, including complementary...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Title: Senior Regulatory Affairs PharmacistJob Summary:We are seeking a Senior Regulatory Affairs Pharmacist to manage work streams for- and report on the assigned portfolio of products. The ideal candidate will have a degree in pharmacy, experience in regulatory affairs, and strong project management skills.Key Responsibilities:Establish regulatory...

  • Head of Regulatory Affairs

    1 month ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job DescriptionJob Title: Head of Regulatory AffairsCompany: Emporium Human CapitalThe Head of Regulatory Affairs holds ultimate responsibility for the OTC division's regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business.Key Responsibilities:Drives the regulatory process to ensure timely...

  • Regulatory Affairs Specialist

    1 month ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Title: Regulatory Affairs SpecialistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Specialist to join our team. 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 Responsibilities:Manage...

  • Regulatory Affairs Specialist

    1 month ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Title: Regulatory Affairs PharmacistCompany: Emporium Human CapitalLocation: Remote OpportunityJob Type: Full-timeSalary: R750KAbout the Role: We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team. The successful candidate will be responsible for managing work streams, reporting on assigned portfolios, and assisting with internal...

  • Regulatory Affairs Specialist

    1 month ago

    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 Role:We are looking for a talented Regulatory Affairs Pharmacist to manage work streams for- and report on the assigned portfolio of products. This includes internal product queries from relevant departments and...

  • Regulatory Affairs Specialist

    2 months ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Title: Regulatory Affairs SpecialistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for managing work streams for assigned portfolios of products, including internal and external product queries, regulatory priorities, and resource...

  • Regulatory Affairs Specialist

    3 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. This is an exciting opportunity for a seasoned professional to leverage their expertise in human medicines, including complementary medicines and medical devices, to drive end-to-end regulatory activities.About the RoleThis role involves...

Regulatory Affairs Manager

2 months ago

Midrand, Gauteng, South Africa The Globevest Group Full time
Regulatory Affairs Manager

Our client, an international pharmaceutical company, is seeking a highly skilled Regulatory Affairs Manager to join their team. As a key member of the regulatory team, you will be responsible for ensuring compliance with all relevant regulations and maintaining the company's pharmacovigilance requirements.

Main Responsibilities:
  • Lead and manage the regulatory affairs function, ensuring seamless product registration and dossier maintenance in the SEA Cluster.
  • Develop and implement regulatory strategies to ensure compliance with relevant regulations and industry standards.
  • Manage and implement safety updates, CMC/P&A updates, and variations, as well as handle license renewals with service providers.
  • Develop and maintain SOPs in line with Global SOPs, manage internal and external audits, and ensure regulatory compliance and quality-related records are available and retained.
  • Coordinate product recalls or market withdrawals, obtain and distribute updated information on domestic and international laws, and report ADRs to Global Safety and SAHPRA.
  • Conduct pharmacovigilance training for local staff and oversee the implementation and maintenance of QMS to ensure compliance with industry standards and regulations.
Requirements:
  • Grade 12
  • B. Pharm
  • Registration with the South African Pharmacy Council (SAPC)
Experience and Skills:
  • 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