Head of Regulatory Affairs

2 weeks ago

Johannesburg, Gauteng, South Africa Unique Personnel Full time

Job Number

  • 71851

Job Type

  • Permanent

Job Title

  • Head of Regulatory Affairs

Computer Skills

  • Ms Office

Industry

  • Manufacture

City

  • Johannesburg (Incl. Northern Suburbs)

Province

  • Gauteng

Reporting To Managing Director - company OTC

Job Purpose

  • The Head of Regulatory Affairs holds ultimate responsibility for the company OTC division's regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business.
  • The Head of Regulatory Affairs will additionally be responsible for oversight of the Group Stability Division.
  • To ensure legal compliance with the relevant Health Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act 101 of 1965, as amended and South African Pharmacy Act (Act 53 of 1974), and other relevant regulations.

Key Job Outputs

  • Drives the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives,
  • Adopts a riskbased assessment for all regulatory submissions and anticipates potential issues for risk mitigation strategies to be in place,
  • Anticipates 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 whilst maintaining sense of urgency,
  • Strives to maintain a high level of quality.
  • Ensures superior execution by combining the best practices of regulatory,
  • Represent RA at operational meetings such as Technical Transfer, QA, Operations, Launch, Artwork/Packaging, Stability and Research & Development, where proactive input can then enhance operational efficiency,
  • Assist the launch team in order to facilitate smooth launch process in line with product and dossier compliance; to manage all the RA aspects of a launch with respect to product launch plan,
  • To give information and input to Responsible Pharmacist in order to facilitate appropriate decision making to ensure that all SAHPRA requirements are timeously met,
  • 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 to the OTC RA Managers,
  • 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 offsite Regulatory Affairs support team,
  • To 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 crossfunctional decisionmaking discussions and Management Escalation and Reporting
    Inherent Requirements

Required Learning

  • Qualifications: B. Pharm Degree Registration with 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,
  • This role requires a high degree of networking and collaboration both within and outside the organization,
  • Demonstrated experience across the product development, commercialization and dossier maintenance lifecycle.

Core Competencies

  • Leadership: Ability to lead and inspire crossfunctional teams, driving collaboration, innovation, and operational excellence,
  • Strategic Thinking: Capability to align projects and initiatives with overall organizational goals, making informed decisions that contribute to longterm success,
  • Project Management: Proficiency in managing complex projects, coordinating resources, and delivering results within specified timelines,
  • Communication: Strong communication skills to facilitate effective collaboration, convey ideas clearly, and build strong relationships with internal and external stakeholders,
  • Problem-Solving: Aptitude for identifying challenges, developing solutions, and addressing obstacles that arise during project execution,
  • Industry Knowledge: Indepth understanding of the pharmaceutical industry, product development, manufacturing processes, and regulatory requirements,
  • Change Management: Ability to drive and manage organizational change, encouraging adoption of new processes and fostering a culture of continuous improvement,
  • Stakeholder Management: Proficient in managing relationships with various stakeholders, ensurin

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