Head of Regulatory Advocacy and Market Access

2 weeks ago

Cape Town, Western Cape, South Africa HR Genie Full time
Job Title: Head of Regulatory Advocacy

We are seeking a highly experienced professional to lead our regulatory advocacy and market access efforts. As the Head of Regulatory Advocacy, you will be responsible for developing and executing strategies to navigate regulatory environments, promote policy frameworks, and secure market access for pharmaceutical products.

Key Responsibilities:
  • Develop and implement regulatory advocacy strategies to influence policy and decision-making within National Regulatory Authorities (NRA) and National Ethics Committees (NEC).
  • Engage with policymakers, Ministry of Health (MoH) officials, and regulatory authorities to advocate for favorable regulations that support market access.
  • 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 in meetings with ethics boards, ensuring adherence to ethical guidelines and prompt resolution of regulatory concerns.
  • Advocate for streamlined submission processes and ethical approval pathways that align with international standards.
  • Oversee the preparation, submission, and approval of regulatory submissions to ensure compliance with local and international regulations.
  • Ensure timely submission of documentation for licensing, renewals, and post-marketing surveillance for pharmaceutical products.
  • Lead the development of robust regulatory strategies to accelerate approvals for market access in new and existing markets.
  • Lead efforts to develop policy frameworks that promote access to medicines through NRA and NEC collaborations.
  • Develop strategies for data sharing agreements that facilitate efficient regulatory approvals and product registrations across borders.
  • Advocate for policy changes that support broader access to pharmaceutical innovations, addressing regulatory hurdles that may hinder product entry into key markets.
  • Build and maintain strategic partnerships with pharmaceutical companies, regulatory bodies, MoH, healthcare providers, and key industry stakeholders to support advocacy efforts.
  • 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.
  • Monitor internal compliance with regulatory obligations, ensuring that all submissions and interactions with authorities are conducted ethically and transparently.
  • Work closely with internal teams to ensure that the company is fully compliant with evolving regulatory frameworks and legal requirements.
Requirements:
  • Bachelor's 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.

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