This position is within the Vaccine and Biotherapeutics Development Programme (VaxBioD).
Responsibilities:
- Develop the regulatory strategy and roadmap for each priority vaccine candidate.
- Ensure platform, protocols, processes, materials, assays, and related documentation are developed with regulatory pathways in mind.
- Lead engagement with the National Pharmaceutical Regulatory Agency (NPRA) and relevant reference regulatory authorities.
- Maintain regulatory documentation and submission readiness.
- Develop and implement Quality Assurance (QA) and Quality Management Systems (QMS) aligned with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards.
- Establish documentation and Standard Operating Procedure (SOP) control processes.
- Prepare the organisation for audit readiness ahead of clinical and manufacturing progression.
- Partner with Research and Bioprocessing teams to embed quality from the start.
Requirements:
- Minimum Bachelor’s Degree in Life Sciences, Pharmacy, or Quality Management. A Master’s or PhD degree is highly preferred.
- At least 5 years’ experience in regulatory affairs, QA, or project coordination in a regulated pharma/biotech/vaccine environment.
- Strong understanding of regulatory submission processes and documentation standards.
- Familiarity with GLP/GMP frameworks and audit processes; NPRA/FDA/EMA experience an advantage.
- Strong stakeholder management, leadership, and organisational skills.