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Head of Regulatory Affairs Director

2 months ago

Midrand, Gauteng, South Africa MNA Recruitment (Pty) Ltd Full time
Head of Regulatory Affairs Job Description

MNA Recruitment (Pty) Ltd is seeking a highly skilled and experienced Head of Regulatory Affairs to join their team. The successful candidate will be responsible for leading the Regulatory Affairs Division and overseeing the development and delivery of a fully integrated regulatory strategy for the business.

Key Responsibilities:
  • Lead the Regulatory Affairs Division and oversee the development and delivery of a fully integrated regulatory strategy for the business.
  • Ensure legal compliance with relevant Health Regulatory Authorities, Medicines and Related Substances Control Act 101 of 1965, as amended, and South African Pharmacy Act (Act 53 of 1974), and other relevant regulations.
  • Drive the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives.
  • Anticipate, communicate, and manage future regulatory changes and impacts on business success.
  • Communicate effectively with internal and external stakeholders to ensure an excellent understanding of Regulatory Affairs.
  • Monitor and measure progress toward objectives and provide feedback on results while maintaining a sense of urgency.
  • Strive to maintain a high level of quality and ensure superior execution by combining the best regulatory practices.
  • Represent RA at operational meetings and provide proactive input to enhance operational efficiency.
  • Assist the launch team to facilitate a smooth launch process in line with product and dossier compliance.
  • Manage the regulatory and compliance aspects of any project launched into operations, including acquisitions and mergers, as well as technical transfer projects.
  • Maintain current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry.
  • Internal Training, Development, and Mentorship of RA Managers.
  • Establish and maintain effective relationships with Regulatory Authorities and internal and external stakeholders.
  • Formulate or implement regulatory affairs systems, policies, and procedures to ensure regulatory compliance is maintained or enhanced.
  • Manage activities such as internal audits or regulatory agency inspections.
  • Manage an off-site Regulatory Affairs support team.
  • Collaborate and support the Group Regulatory Affairs function in achieving the company regulatory strategic objectives and goals.
  • Ensure the Group Stability Department adheres to applicable regulations and company procedures.
Requirements:
  • B. Pharm Degree.
  • Registration with the South African Pharmacy Council.
  • 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.