Head of Regulatory Advocacy & Market Access (Remote)

The successful candidate will develop and execute strategies to navigate regulatory environments, promote policy frameworks, and secure market access for pharmaceutical products.

Responsibilities:

• Lead the development and implementation of regulatory advocacy strategies aimed at influencing 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.
• Serve as the company's representative 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.

Skills:

• Proven ability to build relationships and engage with government bodies, regulatory authorities, and industry stakeholders.
• Excellent communication and negotiation skills, with the ability to influence regulatory policy and advocate for favorable outcomes.
• Strong leadership and project management skills, with experience leading cross-functional teams.
• Strategic thinker with a proactive approach to solving complex regulatory and market access challenges.
• Ability to adapt to a dynamic regulatory environment and influence stakeholders in a professional and ethical manner.
• Demonstrated ability to lead advocacy initiatives, regulatory submissions, and manage multiple projects simultaneously.

Qualifications:

• 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.