Regulatory Affairs Professional

1 week ago

Pretoria, Gauteng, South Africa MNA Recruitment (Pty) Ltd Full time

A Pharmaceutical Leader is seeking a Regulatory Affairs Manager to support the OTC Regulatory team in providing superior Regulatory services.

The primary goal of this role is to ensure legal and regulatory compliance with relevant medicine Regulatory Authorities, ensuring timeous processing of regulatory applications.

Responsibilities include:

  • Managing work streams for assigned portfolios and reporting on progress
  • Assisting with internal product queries from relevant departments
  • Assisting with external product queries from regulatory agencies and third-party stakeholders
  • Establishing regulatory priorities and allocating resources and workloads

Key responsibilities also include co-ordinating and submitting new product applications in South Africa and other applicable territories, including:

  • Developing regulatory strategies and implementation plans
  • Conducting dossier due diligence to address data gaps
  • Preparing registration applications for submission to regulatory authorities

Additionally, the successful candidate will be responsible for ensuring the maintenance and/or update of existing registrations in accordance with relevant legislation, regulations and guidelines. They must maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.

The ideal candidate will have experience in the use of CTD software builder and compilation of eCTD applications, management of personnel resources, 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 set standards and objectives and monitor progress, complex problem-solving and decision-making skills, customer relationships, development of people, and responsibility, excellence and collaboration.

Qualifications include a Bachelor's degree in Pharmacy or Diploma in Pharmacy and Registration with the South African Pharmacy Council, minimum of 5 years' experience in Regulatory Affairs, preferably in human medicines, demonstrable experience across the product development, commercialization and maintenance lifecycle, sound project management capabilities, and proven ability to consistently deliver quality, time and cost standards.

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