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- Tasks: Lead regulatory strategies for vaccine market entry in MENA and beyond.
- Company: Join a dynamic healthcare commercialisation platform focused on innovative vaccine solutions.
- Benefits: Enjoy remote work flexibility and the chance to impact global health.
- Why this job: Be a key player in vaccine commercialisation, bridging global and local regulatory efforts.
- Qualifications: 10+ years in Regulatory Affairs with strong EMA/FDA experience required.
- Other info: Fluency in English is essential; Arabic skills are a bonus.
The predicted salary is between 60000 - 84000 £ per year.
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:
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Lead regulatory interactions between global (US/EU/UK/Japan) and local MENA regulatory teams.
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Translate global dossier content into regionally aligned regulatory strategies.
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Guide deficiency responses, submission planning (Modules 1–5), and alignment with EMA/FDA standards.
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Provide strategic input on CMC documentation and local manufacturing/tech transfer projects.
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Support multiple active programs across vaccines, biologics, and small molecules.
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Collaborate with internal commercial teams to align regulatory and launch timelines.
Requirements:
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10+ years in Regulatory Affairs with strong EMA/FDA exposure.
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Proven experience in vaccine registration and commercialisation.
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Understanding of global dossier development and regulatory gap assessments.
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Familiarity with in-licensing models and early-stage biotech collaboration.
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Strategic mindset with hands-on ability to manage ambiguity across regions.
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English fluency required; Arabic is a plus.
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Regulatory/CMC Contractor employer: Barrington James Limited
Contact Detail:
Barrington James Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory/CMC Contractor
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with vaccine commercialisation. Attend industry conferences or webinars focused on regulatory strategies in the MENA region to make valuable connections.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements for vaccines in the MENA region. Understanding local regulations and guidelines will help you demonstrate your expertise during interviews and discussions.
✨Tip Number 3
Prepare to discuss your previous experiences in managing regulatory submissions and interactions with EMA and FDA. Highlight any successful projects where you navigated complex regulatory landscapes, as this will showcase your strategic mindset.
✨Tip Number 4
Stay updated on the latest trends and developments in vaccine regulation globally. Being knowledgeable about current events and changes in policies can give you an edge in conversations with potential employers.
We think you need these skills to ace Regulatory/CMC Contractor
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Regulatory Affairs, especially focusing on vaccine registration and commercialisation. Use specific examples that demonstrate your familiarity with EMA/FDA standards and your strategic mindset.
Craft a Compelling Cover Letter: In your cover letter, explain why you are the perfect fit for this role. Emphasise your 10+ years of experience in Regulatory Affairs and your ability to bridge global and local regulatory teams. Mention any relevant projects you've worked on in the MENA region.
Highlight Relevant Skills: When filling out your application, ensure you highlight skills that align with the job description, such as your understanding of global dossier development, CMC documentation, and your ability to manage ambiguity across regions.
Proofread Your Application: Before submitting, take the time to proofread your application. Check for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in Regulatory Affairs.
How to prepare for a job interview at Barrington James Limited
✨Showcase Your Regulatory Expertise
Make sure to highlight your extensive experience in Regulatory Affairs, especially your work with EMA and FDA. Be prepared to discuss specific examples of how you've successfully navigated the regulatory landscape for vaccines and biologics.
✨Demonstrate Strategic Thinking
This role requires a strategic mindset, so be ready to share instances where you've developed and implemented regulatory strategies. Discuss how you’ve aligned global dossier content with local regulatory requirements, particularly in the MENA region.
✨Prepare for Technical Questions
Expect technical questions related to CMC documentation and submission planning. Brush up on Modules 1-5 and be ready to explain how you would guide deficiency responses and ensure compliance with EMA/FDA standards.
✨Cultural Awareness and Communication Skills
Since this position involves collaboration across different regions, emphasise your ability to communicate effectively with diverse teams. If you have any experience working in or with the MENA region, make sure to mention it, as it will demonstrate your cultural awareness.
