Regulatory/CMC Contractor

Senior Regulatory Affairs Consultant – Vaccine Commercialisation Focus

Must be EU based | Remote | Focus: MENA, US, EU, UK, Japan | 12 Month, 20 Hours PW Contract Position

My client, a healthcare commercialisation platform operating across the MENA region, is seeking a Senior Regulatory Affairs Consultant to support the market entry and regulatory strategy of in-licensed vaccines and biologics into Saudi Arabia and the broader MENA region.

This role is ideal for an experienced regulatory professional who has directly supported the commercialisation of vaccines in global markets and can operate as a strategic bridge between international product owners and local regulatory stakeholders.

Key Responsibilities:

• Lead regulatory interactions between global (US/EU/UK/Japan) and local MENA regulatory teams.

• Translate global dossier content into regionally aligned regulatory strategies.

• Guide deficiency responses, submission planning (Modules 1–5), and alignment with EMA/FDA standards.

• Provide strategic input on CMC documentation and local manufacturing/tech transfer projects.

• Support multiple active programs across vaccines, biologics, and small molecules.

• Collaborate with internal commercial teams to align regulatory and launch timelines.

Requirements:

• 10+ years in Regulatory Affairs with strong EMA/FDA exposure.

• Proven experience in vaccine registration and commercialisation.

• Understanding of global dossier development and regulatory gap assessments.

• Familiarity with in-licensing models and early-stage biotech collaboration.

• Strategic mindset with hands-on ability to manage ambiguity across regions.

• English fluency required; Arabic is a plus.