Current jobs related to Regulatory Affairs Specialist - Midrand, Gauteng - Emporium

  • Regulatory Affairs Specialist

    2 weeks 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...

  • Regulatory Affairs Specialist

    3 weeks ago

    Midrand, Gauteng, South Africa Emporium Full time

    Job Title: Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Emporium. The successful candidate will be responsible for managing work streams, reviewing regulatory agency submissions, and ensuring compliance with regulatory standards.Key Responsibilities:Manage work streams for...

  • Regulatory Affairs Specialist

    2 weeks 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

    2 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Emporium Human Capital. In this role, you will be responsible for managing work streams and reporting on assigned portfolios of products.Key Responsibilities:Assist with internal product queries from relevant departmentsAssist with...

  • Regulatory Affairs Specialist

    4 weeks 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

    4 weeks ago

    Midrand, Gauteng, South Africa Emporium Full time

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

  • Regulatory Affairs Specialist

    2 weeks 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 Specialist

    1 month ago

    Midrand, Gauteng, South Africa Hire Resolve Full time

    Regulatory Affairs Manager Job DescriptionHire 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 seamless product registration and dossier maintenance, while ensuring compliance with all regulations and pharmacovigilance requirements.Key...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Emporium Human Capital. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for human medicines and medical devices.Key ResponsibilitiesManage work streams for internal and external...

  • Regulatory Affairs Specialist

    2 months 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 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...

  • 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.Job SummaryWe are looking for a Regulatory Affairs Pharmacist with a strong background in pharmaceutical regulations and a proven track record of success in managing regulatory affairs for pharmaceutical products.Key...

  • Regulatory Affairs Specialist

    4 weeks 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. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the quality and safety of our pharmaceutical products.Key Responsibilities:Manage...

  • Regulatory Affairs Specialist

    4 weeks 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

    4 weeks 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 Specialist

    1 month ago

    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 department, you will be responsible for managing work streams and reporting on assigned portfolios of products.Key Responsibilities:Manage internal...

  • Regulatory Affairs Specialist

    1 month 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 human medicines, including complementary medicines and medical devices.Manage end-to-end regulatory activities, ensuring compliance with Good Manufacturing...

  • 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 human medicines, including complementary medicines and medical devices.Manage end-to-end regulatory activities, ensuring compliance with Good Manufacturing...

  • Regulatory Affairs Specialist

    1 month ago

    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 department, you will be responsible for managing work streams and reporting on assigned portfolios of products.Key Responsibilities:Manage internal...

  • Regulatory Affairs Specialist

    2 weeks ago

    Midrand, Gauteng, South Africa Hire Resolve Full time

    Regulatory Affairs Manager Job DescriptionHire Resolve's client is seeking a highly skilled Regulatory Affairs Manager to oversee product registration and dossier maintenance processes.Key ResponsibilitiesDevelop and execute strategic plans for regulatory compliance and product registration.Ensure timely and seamless product registration and dossier...

  • Regulatory Affairs Specialist

    2 weeks ago

    Midrand, Gauteng, South Africa The Recruitment Council Full time

    At The Recruitment Council, we are seeking a skilled Regulatory Affairs Specialist to play a pivotal role in ensuring our organization's compliance with financial regulations and industry guidelines. The successful candidate will oversee compliance with financial regulations and industry guidelines, collaborating closely with legal, compliance, and risk...

Regulatory Affairs Specialist

2 months ago

Midrand, Gauteng, South Africa Emporium Full time
Job Summary

We 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 Responsibilities
  • Regulatory Compliance
    • Manage work streams for- and report on the assigned portfolio of products
    • Assist with internal product queries from relevant departments
    • Assist with external product queries from regulatory authorities and third-party stakeholders
    • Establish regulatory priorities and allocate resources and workloads
  • Regulatory Strategy and Planning
    • Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
    • Develop regulatory strategies and implementation plans for the preparation and submission of new products
    • Conduct dossier due diligence to ensure all data gaps are addressed
  • Registration and Compliance
    • Prepare the registration applications for submission to the regulatory authorities
    • Work in collaboration with internal and external stakeholders to assess regulator's submissions requirements
    • Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
  • Regulatory Affairs Systems and Procedures
    • Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced
    • Support activities such as internal audits or regulatory agency inspections
  • Communication and Collaboration
    • Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
    • Ensure alignment of personal and company values
Requirements
  • Qualifications and Experience
    • Bachelor's degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
    • 3 to 5 years' experience in Regulatory Affairs, preferably in human medicines
  • Skills and Competencies
    • Experience in use of CTD software builder and compilation of eCTD applications
    • IT skills
    • Ability to prioritize and work to tight deadlines
    • Systems and operations analysis
    • Basic cost management skills
    • Active learning
    • Strategic thinking
    • Ability to cope with a high degree of complexity and change
    • Cross Functional skills: Ability to network, liaise and negotiate with others
    • Ability to set standards and objectives and monitor progress
    • Complex problem solving and decision-making skills
    • Customer relationships
    • Development of people