At a Glance
- Tasks: Support regulatory submissions and ensure compliance for innovative medical products.
- Company: Join a leading international healthcare network making breakthroughs in medicine.
- Benefits: Gain valuable experience, work in a dynamic environment, and enjoy career growth opportunities.
- Other info: Collaborate with diverse teams and enhance your skills in a fast-paced setting.
- Why this job: Be part of a team that helps bring new medicines to patients across Europe.
- Qualifications: Degree in life sciences and up to 5 years in the pharmaceutical industry.
The predicted salary is between 35000 - 45000 £ per year.
Do you want to be part of our General Medicines, Vaccines and Infectious Diseases (GenMed-VID) team and help bring new medical advancements to patients? We are an international network on the leading edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world. We have a new, exciting opportunity for a Regulatory Affairs Associate Liaison to be based in Brussels (BE), Oss (NL) or London (UK).
As an Associate Liaison, you will provide procedural, administrative, and planning support for new marketing authorization applications and variation submissions in the EU, UK, Switzerland, and non-EU South Eastern European countries (non-EU SEE) under supervision from the (Senior) Principal Scientist of Regulatory Affairs. You will work on products approved through Centralized and Decentralized/MRP procedures, collaborating with the (Senior) Principal Scientist and cross-functional teams.
Regulatory Affairs Europe is part of Global Regulatory Affairs and Clinical Safety (GRACS). In GRACS we are always striving for operational excellence. We cover a wide range of activities related to getting products and keeping them on the market. The health authority is our most important stakeholder; our end goal is to ensure innovative medicines reach patients. Our large portfolio in GenMed-VID includes medicinal products at all stages of the marketing authorization’s life cycle and spans several therapeutic indications. Activities are numerous and the dedication and commitment of the team is very rewarding. Our portfolio provides the chance to learn something new every day!
What You’ll Do
- Administrative support: Provides administrative support during filling and review of new product registrations and post-approval submissions (variations, CHMP referrals, Agency commitments etc.) in the EU and the UK, Switzerland, and non-EU SEE countries.
- Coordinate submissions: Plan and coordinate regulatory submissions to ensure timely delivery.
- Prepare Module 1: Draft and organize regional administrative documents and liaise with internal teams for completeness and accuracy.
- Collaborate cross-functionally: Work closely with Regulatory Operations and Country RA Managers to establish submission timelines and align on submission strategy and execution.
- Manage translations: For centralized procedures, oversee translation processes to meet EMA requirements.
- Artwork development: Coordinates new product artwork development and/or artwork updates implementation.
- Maintain compliance: Keep regulatory databases updated and ensure adherence to EU legislation and procedural requirements.
- Contribute to projects: Act as a subject matter expert in workstreams and process improvement initiatives.
What We’re Looking For
- University degree in life sciences or related field.
- Up to 5 years of experience in the pharmaceutical industry with knowledge of drug development and approval processes.
- Strong organizational and project management abilities with the ability to manage multiple tasks and to prioritise them efficiently.
- Excellent written and verbal communication in English.
- Familiarity with EU regulatory procedures (CP, DCP, MRP) and Module 1 requirements.
- Ability to work in an international environment and coordinate multiple stakeholders.
- Detail-oriented with strong document review and QC skills.
- Proactive, solution-oriented, and eager to contribute to process improvements.
- Experience with AI-enabled tools (e.g. for document management, data review, process efficiency, or knowledge retrieval).
- Willingness to travel up to 5% for job-related activities.
Required Skills
- Accountability
- Adaptability
- Audits Compliance
- Detail-Oriented
- EU Pharmaceutical Regulations
- Communication
- Pharmacovigilance
- Process Improvements
- Project Management
- Regulatory Compliance
- Regulatory Operations
- Regulatory Strategy Development
- Regulatory Submissions
- Digital & AI literacy
Associate Liaison, Regulatory Affairs Europe employer: MSD
Join our dynamic team in Brussels, Oss, or London, where we are dedicated to advancing healthcare through innovative regulatory solutions. As an employer, we offer a collaborative work culture that values employee growth and development, providing opportunities to learn from industry experts while contributing to meaningful projects that impact patient care. With a commitment to operational excellence and a diverse portfolio, you will find a rewarding environment that encourages professional advancement and embraces new ideas.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Liaison, Regulatory Affairs Europe
✨Tip Number 1
Network like a pro! Reach out to professionals in the Regulatory Affairs field on LinkedIn or at industry events. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU regulatory procedures. Be ready to discuss how your experience aligns with the role, especially around submissions and compliance. We want to see your passion for getting innovative medicines to patients!
✨Tip Number 3
Showcase your organisational skills! During interviews, share examples of how you've managed multiple tasks or projects. Highlighting your ability to prioritise will make you stand out as a candidate who can thrive in a fast-paced environment.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in being part of our team at StudySmarter.
We think you need these skills to ace Associate Liaison, Regulatory Affairs Europe
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Associate Liaison role. Highlight your experience in regulatory affairs and any relevant projects you've worked on. We want to see how your skills align with what we’re looking for!
Showcase Your Communication Skills:Since excellent written communication is key for this role, ensure your application is clear and concise. Use professional language but let your personality shine through. We love a bit of flair!
Highlight Your Organisational Skills:We’re after someone who can juggle multiple tasks efficiently. In your application, mention specific examples where you’ve successfully managed projects or deadlines. This will show us you’re up for the challenge!
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at MSD
✨Know Your Regulatory Stuff
Make sure you brush up on EU regulatory procedures, especially CP, DCP, and MRP. Familiarise yourself with Module 1 requirements and be ready to discuss how your experience aligns with these processes.
✨Show Off Your Organisational Skills
As an Associate Liaison, you'll need to juggle multiple tasks. Prepare examples from your past where you've successfully managed projects or coordinated submissions. Highlight your ability to prioritise effectively.
✨Communicate Clearly
Since excellent communication is key in this role, practice articulating your thoughts clearly and concisely. Be prepared to explain complex regulatory concepts in simple terms, as you may need to liaise with various stakeholders.
✨Be Proactive and Solution-Oriented
Demonstrate your proactive nature by discussing instances where you've identified issues and implemented solutions. Show that you're eager to contribute to process improvements and can think on your feet.
