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Regulatory Advocacy Leader

2 months ago

Cape Town, Western Cape, South Africa HR Genie Full time
About the Role

We are seeking a highly experienced and skilled Regulatory Advocacy Leader to lead our client's regulatory strategy and advocacy efforts. This key leadership role will involve engagement with national and international regulatory bodies, ethics boards, and market access stakeholders.


Key Responsibilities


  • Develop and execute strategies to navigate regulatory environments and promote policy frameworks for market access.
  • Engage with policymakers, Ministry of Health (MoH) officials, and regulatory authorities to advocate for favorable regulations.
  • Monitor legislative and regulatory developments to ensure alignment with evolving healthcare policies and global regulatory requirements.
  • Establish and maintain strong relationships with National Ethics Boards and NRA to facilitate the approval of clinical trials and new pharmaceutical products.
  • Represent the company at industry forums, regulatory conferences, and advocacy groups to ensure strong networks and influence within the regulatory landscape.
  • Collaborate with internal and external stakeholders to gather insights and develop a proactive approach to regulatory engagement.
  • Ensure all regulatory activities comply with national and international legal, ethical, and compliance standards.

Requirements


  • Bachelors degree in Pharmacy, Life Sciences, or a related field (required).
  • Advanced degree (Masters or PhD) in Regulatory Affairs, Pharmaceutical Sciences, or a related discipline is preferred.
  • Minimum of 7-10 years of experience in pharmaceutical regulatory affairs or market access roles, with a strong background in regulatory submissions and policy advocacy.
  • Proven experience engaging with National Regulatory Authorities (NRA), National Ethics Committees (NEC), and Ministry of Health (MoH) officials.
  • Experience in navigating submission requirements, licensing, and regulatory policy development for pharmaceutical products.
  • Strong understanding of regulatory frameworks, submission processes, and ethical guidelines in the pharmaceutical industry.