Head of Regulatory Affairs

2 months ago

Midrand, South Africa MNA Recruitment (Pty) Ltd Full time
A prominent Pharmaceutical Company is seeking a Head of Regulatory Affairs Division to join their team.

The Head of Regulatory Affairs holds ultimate responsibility for the 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 Department. 
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.
The incumbent will serve on the Divisional Leadership team and will therefore be required to act with agility and entrepreneurial flair in driving the financial and compliance objectives of the division.

Responsibilities:
  • 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.
  • Drives the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives.
  • Adopt 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 toward objectives and provides feedback on results whilst maintaining a 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, where proactive input can then enhance operational efficiency.
  • Assist the launch team in order to facilitate a smooth launch process in line with product and dossier compliance; to manage all the RA aspects of a launch with respect to the product launch plan.
  • To give information and input to the Group Responsible Pharmacist in order to facilitate appropriate decision making, ensuring 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 of the 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 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.
  • 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 cross-functional decision-making discussions and Management Escalation and Reporting.
Core Competencies:
  • Leadership: Ability to lead and inspire cross-functional teams, driving collaboration, innovation, and operational excellence.
  • Strategic Thinking: Capability to align projects and initiatives with overall organisational goals, making informed decisions that contribute to long-term 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: In-depth understanding of the pharmaceutical industry, product development, manufacturing processes, and regulatory requirements.
  • Change Management: Ability to drive and manage organisational change, encouraging the adoption of new processes and fostering a culture of continuous improvement.
  • Stakeholder Management: Proficient in managing relationships with various stakeholders, ensuring alignment, and driving successful project outcomes.
Requirements:
  • 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.
Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com
Should you receive no feedback within 7 days, please accept your application as unsuccessful.

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