Regulatory Affairs Specialist

4 days ago

Johannesburg South, South Africa Emporium Full time

Job Overview

We are seeking an experienced Regulatory Affairs Specialist to join our team at Emporium. As a key member of our team, you will be responsible for managing work streams and reporting on assigned portfolios of products.

About the Role

The successful candidate will have a strong background in regulatory affairs, preferably in human medicines, including complementary medicines and medical devices. You will have demonstrated experience across the product development, commercialization, and maintenance lifecycle.

You will be responsible for establishing regulatory priorities, allocating resources and workloads, and reviewing regulatory agency submissions to ensure accuracy, comprehensiveness, and compliance with regulatory standards.

Your Key Responsibilities

  • Manage work streams for- and report on the assigned portfolio of products: internal product queries from relevant departments, external product queries from the SAHPRA, other MRA's 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.
  • Coordinate and submit new product applications in South Africa and other applicable territories.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products, with a focus on complementary medicines and medical devices.
  • Conduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicines and other human medicines.
  • Prepare the registration applications for submission to the regulatory authorities.
  • Work in collaboration with internal and external stakeholders to assess regulator's submissions requirements.
  • Maintain current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry.
  • Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained.

About You

To be successful in this role, you will need:

Experience in use of CTD software builder and compilation of eCTD dossier applications.IT skills including Microsoft Office.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.Must demonstrate responsibility, excellence, and collaboration and align with Company values.

What We Offer

We offer a competitive salary package, including a base salary of R 900 000 - R 1 000 000 per annum, depending on experience and qualifications.

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