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- Tasks: Lead regulatory submissions for innovative biopharmaceutical products across multiple regions.
- Company: Join a global leader in biopharmaceuticals, known for groundbreaking therapies in neurology and rare diseases.
- Benefits: Enjoy flexible working options and the chance to work with a high-performing team.
- Why this job: Be part of a mission-driven company making a real impact on global health.
- Qualifications: Strong experience in regulatory affairs is essential; familiarity with Veeva Vault is a bonus.
- Other info: This role offers exposure to diverse international markets and collaboration with cross-functional teams.
The predicted salary is between 54000 - 84000 £ per year.
Location: UK BASED (covering Asia Pacific, Latin America, Central & Eastern Europe)
Company: Global Biopharmaceutical Leader
Your new company
This is an exciting opportunity to join a leading global biopharmaceutical company, renowned for its innovation in neurological and rare disease therapies. You will be part of a high-performing regulatory team supporting product expansion across 70+ international growth markets.
Your new role
As a Senior Regulatory Affairs Consultant, you will lead regulatory submissions for 1-3 products across Asia Pacific, LATAM, and Central & Eastern Europe. You will be a key member of the global regulatory project team, collaborating closely with the Global Regulatory Lead (GRL) and cross-functional partners in medical writing, pharmacovigilance, clinical, and CMC.
You will oversee the operational work of a CRO, ensuring timely and compliant submissions, and play a central role in implementing regional regulatory strategies aligned with EU, US, and Swiss standards. The role also includes lifecycle management (LCM), core data sheet (CDS) compliance, and managing readiness-to-questions (RTQs). Familiarity with Veeva Vault is a plus, as the platform is being introduced.
What you will need to succeed
Strong regulatory affairs experience...
INTERNATIONAL Regulatory Affairs Contract-Senior manager / AD employer: Click To Hired
Contact Detail:
Click To Hired Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land INTERNATIONAL Regulatory Affairs Contract-Senior manager / AD
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in international markets. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory submissions.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements for the Asia Pacific, Latin America, and Central & Eastern Europe regions. Understanding the nuances of these markets can give you an edge during interviews and demonstrate your commitment to the role.
✨Tip Number 3
Showcase your experience with lifecycle management and compliance in previous roles. Be prepared to discuss specific examples of how you've successfully navigated regulatory challenges and contributed to product submissions in a global context.
✨Tip Number 4
If you have experience with Veeva Vault or similar platforms, make sure to highlight this in conversations. Familiarity with digital tools used in regulatory affairs can set you apart from other candidates and show that you're ready to hit the ground running.
We think you need these skills to ace INTERNATIONAL Regulatory Affairs Contract-Senior manager / AD
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, especially in the biopharmaceutical sector. Emphasise any previous roles where you led regulatory submissions or worked with international markets.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the requirements of the Senior Regulatory Affairs Consultant role. Mention your familiarity with regulatory strategies and any experience with Veeva Vault, as this is a plus for the position.
Highlight Key Achievements: In both your CV and cover letter, include specific examples of successful regulatory submissions you've managed. Quantify your achievements where possible, such as the number of products submitted or markets expanded.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents. Check for spelling and grammatical errors, and ensure that your writing is clear and professional. A polished application reflects your attention to detail.
How to prepare for a job interview at Click To Hired
✨Understand the Regulatory Landscape
Make sure you have a solid grasp of the regulatory frameworks in Asia Pacific, Latin America, and Central & Eastern Europe. Familiarise yourself with the specific requirements for submissions in these regions, as this knowledge will demonstrate your expertise and readiness for the role.
✨Showcase Your Collaborative Skills
As this role involves working closely with cross-functional teams, be prepared to discuss your experience in collaboration. Highlight specific examples where you've successfully worked with medical writing, pharmacovigilance, or clinical teams to achieve regulatory goals.
✨Familiarity with Veeva Vault
If you have experience with Veeva Vault, make sure to mention it during the interview. If not, take some time to research the platform and understand its functionalities, as this could give you an edge over other candidates.
✨Prepare for Lifecycle Management Questions
Since lifecycle management is a key part of the role, be ready to discuss your approach to managing product lifecycles. Think about how you would handle compliance issues and readiness-to-questions, and be prepared to provide examples from your past experiences.
