We are seeking a highly experienced Head of Regulatory Advocacy & Market Access with a background in the pharmaceutical industry 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.
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.