Regulatory Affairs Professional

5 days ago

Pretoria, Gauteng, South Africa MNA Recruitment Full time
Job Description:

A vacancy exists for a highly skilled Regulatory Affairs Professional to lead the Regulatory team in providing superior regulatory services to relevant departments within the company and external partners.

Key Responsibilities:

  1. Manage work streams for assigned portfolios, reporting on progress and outcomes.
  2. Assist with internal product queries from relevant departments, ensuring timely resolutions.
  3. Liaise with external stakeholders, including SAHPRA and other MRA's, to resolve product queries.
  4. Establish regulatory priorities, allocating resources and workloads effectively.
  5. Review regulatory agency submissions to ensure accuracy, comprehensiveness, and compliance with regulatory standards.
  6. Coordinate the submission of new product applications in South Africa and other territories, including:
    1. Developing regulatory strategies and implementation plans.
    2. Conducting dossier due diligence to address data gaps.
    3. Preparing registration applications for submission to regulatory authorities.
    4. Collaborating with NBD to assess regulator's submission requirements.
    5. Maintaining existing registrations in accordance with relevant legislation, regulations, and guidelines.
    6. Staying up-to-date with current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry.
    7. Providing internal training and mentoring.
    8. Establishing and maintaining effective relationships with Regulatory Authorities and internal/external stakeholders.
    9. Formulating or implementing regulatory affairs systems, policies, and procedures to ensure regulatory compliance.
    10. Managing activities such as internal audits or regulatory agency inspections.
    11. Aligning personal and company values.

Requirements:

  1. Bachelor's degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council.
  2. Minimum 5 years' experience in Regulatory Affairs, preferably in human medicines, with demonstrated experience across the product development, commercialization, and maintenance lifecycle.
  3. Experience in using CTD software builder and compiling eCTD applications will be an advantage.
  4. Sound project management capabilities.
  5. Proven ability to deliver to quality, time, and cost standards and possess professional people management experience.

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