Medical & Regulatory Affairs Specialist

Location: Remote (Global)
Type: Full-time / Consultant

Overview:

At LunaVax, we’re advancing next-generation vaccines to reach communities faster, safer, and more equitably. As a Medical & Regulatory Affairs Specialist, you’ll play a critical role in ensuring our products meet rigorous safety, efficacy, and compliance standards. From drafting global submissions to engaging with regulatory bodies across Africa and beyond, you’ll help navigate the path from innovation to licensure. Your work will directly support the approval and responsible rollout of LunaVax’s microneedle patches and mobile immunization platforms.

This is a high-responsibility, high-impact position for someone who thrives at the intersection of science, policy, and access.

Responsibilities:

• Prepare, compile, and manage regulatory submissions including CTD/eCTD documentation
• Engage with national and international regulatory authorities (e.g., NAFDAC, FDA, WHO, NRAs)
• Monitor and manage safety reporting, trial SOPs, and adverse event documentation
• Support alignment with Good Clinical Practice (GCP), ICH, and local regulatory frameworks
• Contribute to labeling, protocol amendments, and investigator brochures as needed

Preferred Qualifications:

• PharmD, MD, MPH, or advanced certification in regulatory affairs (e.g., RAC)
• 3–5 years of hands-on experience in medical/regulatory affairs
• Familiarity with regulatory pathways for vaccines or biologics in Africa and LMICs
• Strong writing skills and attention to regulatory detail
• Experience with submissions to WHO PQ, NAFDAC, or similar regional bodies is a plus

What You’ll Gain:

• Ownership of regulatory strategy in a mission-driven biotech
• High-impact work supporting vaccine access in underserved communities
• Cross-functional collaboration with medical, clinical, and global policy teams
• Opportunities to shape policy-aligned product rollout from lab to field

Compensation:
Estimated range: $90,000 – $130,000 USD annually, depending on experience and location.

Interested in this role?

We’re excited to learn more about you. Please complete the form above to share your interest. Our team carefully reviews all applications and will be in touch if your profile aligns with our current needs.

Thanks for considering LunaVax!