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Regulatory Affairs Specialist

2 months ago

Johannesburg South, South Africa Emporium Human Capital Full time
Regulatory Affairs Manager

Aeroton

Salary R1m to R1.2 mil per annum

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
  • Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products, with a focus on complementary

medicines and medical devices.

Key Outputs

  • 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
  • Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines

for variations (CMC & Labelling), Renewals, Artwork updates etc.

  • 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
  • Ensure alignment of personal and company values
  • Core Competencies
  • 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