Regulatory Affairs Pharmacist: OTC Position

3 weeks 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.

About the Role: As a Regulatory Affairs Pharmacist, you will be responsible for managing work streams for assigned products, establishing regulatory priorities, and allocating resources and workloads.

Key Responsibilities:

  • Manage work streams for- and report on the assigned portfolio of products
  • Internal product queries from relevant departments
  • External product queries from regulatory authorities and third-party stakeholders
  • Establish regulatory priorities and allocate resources and workloads
  • Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
  • Co-ordination and submission of new product applications in South Africa and other applicable territories
  • 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
  • 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
  • Update and maintain databases, trackers and systems for all regulatory related activities
  • Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained
  • Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry
  • Internal training and mentoring of peers when required
  • Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
  • 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

Requirements:

  • Experience in use of CTD software builder and compilation of eCTD dossier applications
  • IT skills including Microsoft Office
  • Ability to prioritise 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

How to Apply: Please send your MS Word format CV to the designated email address and use the job reference number in the subject line.



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

    Job Title: Senior Regulatory Affairs Pharmacist with OTC ExpertiseJob Summary: We are seeking a highly skilled Senior Regulatory Affairs Pharmacist with expertise in OTC products to join our team at Emporium Human Capital.This role involves managing work streams and reporting on assigned portfolios of products, establishing regulatory priorities, and...


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

    OverviewElevate your career in regulatory affairs with a leading position at Emporium Human Capital. We are seeking a Senior Regulatory Affairs Pharmacist to join our team, bringing expertise in OTC products and a passion for compliance.


  • 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...


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

    Regulatory Affairs Pharmacist (OTC) RoleLocation: MidrandSalary: R900 - R1mQualifications:Bachelor's Degree in Pharmacy with Registration with the South African Pharmacy Council5+ years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activitiesDemonstrable...


  • Midrand, Gauteng, South Africa Jordan HR Full time

    Job TitleSenior Regulatory Affairs PharmacistAbout Jordan HRJordan HR is a reputable organization seeking a highly skilled and experienced Senior Regulatory Affairs Pharmacist to join our team.Job SummaryWe are looking for a seasoned professional with expertise in regulatory affairs, pharmaceutical production experience, and excellent IT skills. The ideal...


  • 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...


  • 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 productsEstablish regulatory priorities and allocate resources and workloadsReview regulatory agency submission of materials to ensure...


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

    Emporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our Complimentary Medicine Division, you will play a critical role in ensuring compliance with regulatory standards.Salary: R900,000 - R1,000,000 per annumAbout the Role:We are looking for an experienced Regulatory Affairs Pharmacist to...


  • 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 assigned portfolios of products and report on progress.Assist with internal and external product queries from relevant departments and regulatory authorities.Establish...


  • Midrand, Gauteng, South Africa Emporium Full time

    Job Title: Regulatory Affairs PharmacistJob Summary: We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium. The successful candidate will be responsible for managing work streams, reporting on assigned portfolios, and ensuring regulatory compliance.Key Responsibilities:Manage work streams for assigned portfolios of...


  • 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 organization, you will be responsible for managing work streams, establishing regulatory priorities, and ensuring compliance with regulatory standards.Key Responsibilities:Manage work streams for...


  • Midrand, Gauteng, South Africa Emporium Full time

    Emporium seeks a highly skilled Regulatory Affairs Pharmacist to spearhead our OTC product development and commercialization efforts in South Africa.Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry. Demonstrate responsibility, excellence and collaboration and align with Company values.Key Job...


  • Midrand, Gauteng, South Africa Emporium Full time

    Job Title: Senior Regulatory Affairs Pharmacist: Pain, DermaEmporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team. 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 and external...


  • 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...


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

        Job Title: Senior Regulatory Affairs Pharmacist: Pain, Derma    Job Reference: POS24205    Emporium Human Capital is seeking a highly skilled Senior Regulatory Affairs Pharmacist: Pain, Derma to join their team. As a key member of the Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements for...


  • Midrand, Gauteng, South Africa Emporium Full time

    Job Title: Head of Regulatory AffairsEmporium is seeking a highly skilled and experienced Head of Regulatory Affairs to lead our OTC division's regulatory activities and develop a fully integrated regulatory strategy for the business.Key Responsibilities:Oversee the development and delivery of a regulatory strategy for the OTC division.Ensure legal...


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

    Job Title: Regulatory Affairs PharmacistCompany: Emporium Human CapitalJob Summary: We are seeking a highly skilled Regulatory Affairs Pharmacist to manage work streams, report on assigned portfolios, and establish regulatory priorities.Key Responsibilities:Manage internal and external product queries from relevant departments and regulatory...


  • Midrand, Gauteng, 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 managing work streams, establishing regulatory priorities, and allocating resources and workloads.Key Responsibilities:Manage work streams for- and report on...


  • 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...


  • 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...