Head of Regulatory Advocacy & Market Access (JB4807)
Remote, for applicants residing in Africa
Market Related
Duration: Permanent
We are seeking a highly experienced Head of Regulatory Advocacy & Market Access to lead regulatory strategies and advocacy efforts within the pharmaceutical sector. This leadership role requires engagement with national and international regulatory bodies, ethics boards, and key market access stakeholders. The ideal candidate will develop strategies to navigate complex regulatory environments, promote policy frameworks, and secure market access for pharmaceutical products, ensuring alignment with evolving healthcare regulations.
The role is remote based with occasional travel required for regulatory meetings, industry conferences, and stakeholder engagement.
Minimum Requirements:
Bachelor’s degree in Pharmacy, Life Sciences, or a related field (required). Advanced degree (Master’s or PhD) in Regulatory Affairs, Pharmaceutical Sciences, or related discipline preferred.
7-10 years in pharmaceutical regulatory affairs or market access roles, with expertise in regulatory submissions, policy advocacy, and engagement with National Regulatory Authorities (NRA), National Ethics Committees (NEC), and Ministry of Health (MoH) officials.
Strong understanding of regulatory frameworks, submission processes, and ethical guidelines.
Proven ability to build relationships with government bodies, regulatory authorities, and industry stakeholders.
Excellent communication, negotiation, leadership, and project management skills.
Duties and Responsibilities:
Regulatory Advocacy & Policy Development: Lead the creation and implementation of regulatory advocacy strategies, influencing policy and decision-making within NRAs and NECs. Monitor legislative developments to align with healthcare policies and global regulatory standards.
National Ethics Boards & Regulatory Engagement: Establish relationships with ethics boards and NRAs to facilitate clinical trial approvals. Represent the company in meetings with ethics boards and advocate for streamlined processes.
Submission and Licensing: Oversee regulatory submissions, ensuring compliance with local and international regulations. Lead licensing renewals and post-marketing surveillance processes.
Market Access & Policy Framework Development: Develop policy frameworks and strategies to promote access to medicines, focusing on overcoming regulatory hurdles and expanding product reach across borders.
Networking & Stakeholder Engagement: Build partnerships with pharmaceutical companies, regulatory bodies, and healthcare providers. Represent the company at industry forums and conferences to influence regulatory landscapes.
Compliance & Ethical Governance: Ensure all regulatory activities meet legal, ethical, and compliance standards. Monitor and ensure internal compliance with regulatory obligations.
Please do not apply using Scanned CVs, no supporting documentation is required at this point, this will be requested later.
IMPORTANT: We specialize in specific niche fields. Regret that we are unable to provide assistance for any fields outside of this scope. Fields can be viewed on our website.
Kontak Recruitment Disclaimer:
Equal opportunity: All backgrounds are welcomed, with no bias. All are considered based on requirements.
Job specifics: Requirements mirror advertisement, duties may adjust for client needs.
Fair process: Fair assessment, only shortlisted candidates contacted due to volume.
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