Head of Regulatory Affairs

2 months ago


Midrand, Gauteng, South Africa Emporium Human Capital Full time
Job Description

Job Title: Head of Regulatory Affairs

Company: Emporium Human Capital

The Head of Regulatory Affairs holds ultimate responsibility for the OTC division's regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business.

Key Responsibilities:

  • Drives the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives.
  • A adopts a risk-based assessment for all regulatory submissions and formulates regulatory risk mitigation strategies, as applicable.
  • Anticipates, communicates, and manages future regulatory changes and impacts on business success.
  • Communicates to ensure an excellent understanding of Regulatory Affairs.
  • Pays strict attention to detail and accurately monitors and measures progress towards objectives and provides feedback on results while maintaining a sense of urgency.
  • Strives to maintain a high level of quality. Ensures superior execution by combining the best regulatory practices.
  • Represents RA at operational meetings such as Group Regulatory, Technical Transfer, QA, Operations, Launch, Artwork/Packaging, Stability, and Research & Development.
  • Assists the launch team to facilitate a smooth launch process in line with product and dossier compliance.

Requirements:

  • A minimum of 8 years of pharmaceutical regulatory experience is an absolute prerequisite.
  • A minimum of 5 years in people or team management is required.
  • This role requires a high degree of networking and collaboration both within and outside the organisation.
  • Demonstrated experience across the product development, commercialisation, and dossier maintenance lifecycle.


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