Regulatory Affairs Director

20 hours ago

Midrand, Gauteng, South Africa Emporium Human Capital Full time

Job Summary:

The Head of Regulatory Affairs will be responsible for driving the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives. This role requires a high degree of networking and collaboration both within and outside the organisation.

Key Responsibilities:

  • Adopt a risk-based assessment for all regulatory submissions and formulate regulatory risk mitigation strategies, as applicable.
  • Anticipate, communicate and manage future regulatory changes and impacts on business success.
  • Communicate 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 whilst maintaining sense of urgency.
  • Strives to maintain a high level of quality.
  • Ensures superior execution by combining the best regulatory practices.
  • Represent RA at operational meetings such as Group Regulatory, Technical Transfer, QA, Operations, Launch, Artwork/Packaging, Stability and Research & Development.
  • Assist the launch team in order to facilitate 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.
  • 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.
  • Manage activities such as internal audits or regulatory agency inspections.
  • Manages 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 Group Stability Department adheres to applicable regulations and company procedures.
  • Represent Group Stability Department in cross-functional decision-making discussions and Management Escalation and Reporting.

Requirements:

  • B. Pharm Degree
  • Registration with South African Pharmacy Council
  • A minimum of 8 years of pharmaceutical regulatory experience
  • A minimum of 5 years in people or team management

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