Vaccines Development & Regulatory Strategy Lead

Location: Remote (Global)
Type: Part-time or Advisory

Overview:

At LunaVax, we’re advancing innovation beyond the lab — into regulatory pathways, public health systems, and real-world impact. As our Vaccines Development & Regulatory Strategy Lead, you’ll play a pivotal role in shaping the regulatory foundation for LunaVax’s microneedle patches (MAPs) and other next-generation immunization platforms — beginning with feasibility-stage evaluations and expanding toward future registration strategies.

From early scientific dialogue with regulators to long-term filing strategy and global market planning, you’ll help us navigate the complex, fast-evolving landscape of vaccine development — especially across African and LMIC markets. You’ll also work closely with our clinical, formulation, and partnerships teams to ensure alignment between innovation and regulatory feasibility.

Responsibilities:

• Define early-stage regulatory strategy for MAPs and other LunaVax vaccine concepts — including feasibility studies, ethical approvals, and future clinical development planning across African, WHO PQ, and international markets
• Lead early scientific engagement with NRAs and regulatory bodies (e.g., NAFDAC, WHO PQ, EMA, FDA) to align expectations
• Scope timelines, costs, and regulatory requirements for product development, clinical trials, and market authorization
• Advise on data generation plans, including non-clinical, clinical, and real-world evidence to support registration
• Guide preparation of ethical approvals, trial submissions, and dossier documentation for new immunization platforms
• Monitor regulatory trends, guidance, and precedents related to novel vaccine delivery technologies (e.g., microneedle patches, thermostable formats)
• Contribute to early-stage discussions with stakeholders and regulators to ensure pilot designs align with future pathway expectations

Preferred Qualifications:

• 7+ years in regulatory affairs, clinical development, or vaccine registration (biotech or public health settings)
• Experience working with regulatory authorities in Africa and/or global pathways (e.g., WHO PQ, FDA, EMA)
• Proven track record navigating regulatory frameworks for novel or combination vaccines
• Familiarity with delivery innovations (e.g., MAPs, intradermal injection, thermostable platforms)
• Strong scientific writing and cross-functional collaboration skills
• Passion for equity-focused innovation in global health

What You'll Gain:

• A leadership role in one of Africa’s most promising early-stage biotech initiatives
• The opportunity to lay the foundation for future regulatory pathways — starting with feasibility planning and advancing toward MAP registration strategies
• A voice in the scientific, ethical, and public health strategy behind LunaVax’s scale-up
• Collaboration with top scientists, product developers, and global health partners
• A flexible, part-time advisory role with potential to grow into broader clinical/regulatory leadership

Compensation:

Consulting fee or milestone-based structure, negotiable based on experience and engagement level. Flexible terms available. While LunaVax currently operates as an LLC, long-term participation incentives including potential equity upon corporate conversion may be considered for candidates aligned with our long-term vision and scale-up strategy.

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!