At a Glance
- Tasks: Coordinate regulatory activities for new and registered medicines across Europe.
- Company: Join a leading pharmaceutical company focused on innovative healthcare solutions.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic international team with a focus on operational excellence and compliance.
- Why this job: Make a real impact by ensuring innovative medicines reach patients in need.
- Qualifications: Master's degree in pharmacy or chemistry with 2 years of industry experience preferred.
The predicted salary is between 40000 - 50000 € per year.
Do you want to be part of our Regulatory Affairs Europe team, supporting accessibility to our new and already registered medicines? We have a new, exciting opportunity for a Regulatory Affairs Liaison to be based in Oss (NL), Brussels (BE), or London (UK).
Purpose of the position
In this role, you will have the opportunity to coordinate regulatory activities in the EU, UK, Switzerland, and non‑EU SEE countries under the supervision of the (Senior) Principal Scientist of Regulatory Affairs. You will be responsible for implementing strategies for products in development with their guidance and independently developing and executing strategies for registered products. Additionally, you will play a crucial role in managing submissions and interactions with the EU regulatory agencies. It will be your responsibility to directly liaise with HQ US‑based cross‑functional teams, effectively communicating regional requirements and ensuring compliance with all necessary regulations for assigned projects. You will also coordinate or oversee the preparation of regulatory documentation in a timely manner, aligning with corporate objectives. Furthermore, as an integral part of the team, you will serve as the Regulatory Affairs representative on assigned non‑product related cross‑functional teams.
The department
Regulatory Affairs Europe is part of Global Regulatory Affairs and Clinical Safety (GRACS). In GRACS we are always striving for operational excellence. Our group covers a wide range of activities related to getting products on the market and keeping them on the market. The health authority is our most important stakeholder; our end goal is to ensure innovative medicines reach patients.
Primary activities
- Under supervision from the (Senior) Principal Scientist, coordinate the preparation, review, and submission of regulatory dossiers for new product registrations and post‑approval submissions in the EU, UK, Switzerland, and non‑EU SEE countries.
- Work with cross‑functional project teams to develop and implement regulatory strategies, including scientific advice, pediatric investigational plans, and orphan designation.
- Identify regulatory risks and ensure alignment of regulatory strategies with project teams and business objectives.
- Accountable for interacting with regulatory agencies and Country RA teams to facilitate smooth submission, assessment, and quick approval of CTAs under the EU Clinical Trial Regulation.
- Serve as the primary regulatory representative to regulatory agencies and Country RA teams.
- Act as the Regulatory Affairs representative on assigned non‑product related cross‑functional teams.
- Develop and implement effective processes to meet business objectives and ensure compliance with regulatory requirements.
- Continuously build and maintain a sound scientific knowledge and expertise in assigned product areas and regulations.
Your profile
- Master's degree in pharmacy, chemistry, or equivalent, preferably in a science‑related field. Minimum of 2 years of experience in the pharmaceutical industry is preferred.
- Strong organizational and planning skills, with the ability to manage multiple projects and adapt to changing priorities.
- Knowledge of EU regulations, guidelines, and regulatory processes for product life cycle maintenance.
- Ability to work in a cross‑functional and international environment.
- Fluent written and spoken English is required, along with strong interpersonal, oral, and written communication skills.
- Digital & AI literacy (use of AI‑enabled tools to support regulatory, administrative, and process‑improvement activities).
- Willingness to travel up to 5% for job‑related activities.
Regulatory Affairs Liaison employer: MSD
Join our dynamic Regulatory Affairs Europe team, where we prioritise innovation and collaboration in the pharmaceutical industry. Based in vibrant locations like Oss, Brussels, or London, we offer a supportive work culture that fosters professional growth and development, alongside competitive benefits. As a Regulatory Affairs Liaison, you will play a pivotal role in ensuring that life-changing medicines reach patients, all while working with cross-functional teams in a fast-paced, international environment.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Liaison
✨Network Like a Pro
Get out there and connect with people in the industry! Attend events, join online forums, or even hit up LinkedIn. The more you chat with folks in Regulatory Affairs, the better your chances of landing that dream job.
✨Show Off Your Skills
When you get the chance to meet potential employers, don’t hold back! Share your knowledge about EU regulations and your experience in the pharmaceutical industry. Let them see how you can add value to their team.
✨Ace the Interview
Prepare for those interviews by brushing up on common questions related to regulatory affairs. Think about how your past experiences align with the role and be ready to discuss specific examples. Confidence is key!
✨Apply Through Us!
Don’t forget to check out our website for openings! Applying directly through us not only shows your interest but also gives you a better chance to stand out. We’re excited to see what you bring to the table!
We think you need these skills to ace Regulatory Affairs Liaison
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the Regulatory Affairs Liaison role. Highlight any relevant experience in regulatory processes, especially within the EU, UK, or Switzerland.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background makes you a perfect fit for our team at StudySmarter.
Showcase Your Communication Skills:Since this role involves liaising with various teams and regulatory agencies, make sure to demonstrate your strong written communication skills in your application. Clear and concise language goes a long way!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands and shows us you’re serious about joining our team!
How to prepare for a job interview at MSD
✨Know Your Regulations
Make sure you brush up on EU regulations and guidelines relevant to the pharmaceutical industry. Being able to discuss specific regulatory processes and how they apply to product life cycles will show that you're not just familiar with the basics, but that you can navigate the complexities of the role.
✨Showcase Your Organisational Skills
Prepare examples from your past experiences where you successfully managed multiple projects or adapted to changing priorities. This will demonstrate your strong organisational and planning skills, which are crucial for a Regulatory Affairs Liaison.
✨Communicate Effectively
Since you'll be liaising with cross-functional teams and regulatory agencies, practice articulating your thoughts clearly and concisely. Use the STAR method (Situation, Task, Action, Result) to structure your responses during the interview, ensuring you highlight your communication skills.
✨Emphasise Your Teamwork Experience
Be ready to discuss your experience working in cross-functional and international environments. Highlight any collaborative projects you've been part of, as this role requires effective interaction with various teams, including those based in the US.
