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- Tasks: Coordinate regulatory activities across Europe and manage submissions with EU agencies.
- Company: Join a leading pharmaceutical company focused on innovation and compliance.
- Benefits: Enjoy a competitive salary, flexible work arrangements, and opportunities for professional growth.
- Why this job: Make a real impact in the pharmaceutical industry while working with diverse teams.
- Qualifications: Master's degree in a science-related field and 2 years of industry experience preferred.
- Other info: Dynamic role with international exposure and excellent career advancement opportunities.
The predicted salary is between 36000 - 60000 ÂŁ per year.
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 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.
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.
- 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.
- Willingness to travel up to 5% for job‑related activities.
- Data Analysis
- EU Regulations
- Pharmaceutical Guidelines
- Process Improvements
- Product Lifecycle
- Product Registrations
- Project Tasks
- Regulatory Affairs Management
- Regulatory Communications
- Regulatory Compliance
- Regulatory Documents
- Regulatory Experience
- Regulatory Filings
- Regulatory Impact Assessment
- Regulatory Reporting
- Regulatory Risk
- Regulatory Strategy Development
- Stakeholder Management
Regulatory Affairs Liaison M/F/D employer: Merck
Contact Detail:
Merck Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Liaison M/F/D
✨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 lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their regulatory challenges and think about how your skills can help them navigate these. Show them you’re not just another candidate!
✨Tip Number 3
Practice your communication skills. As a Regulatory Affairs Liaison, you’ll need to convey complex information clearly. Mock interviews with friends can help you refine your pitch and boost your confidence.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Affairs Liaison M/F/D
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the job description. Highlight your knowledge of EU regulations and any relevant experience in regulatory affairs to catch our eye!
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 the role. Keep it concise but impactful!
Showcase Your Communication Skills: Since this role involves liaising with various teams and agencies, demonstrate your strong communication skills in your application. Use clear and professional language to show us you can effectively convey complex information.
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 Merck
✨Know Your Regulations
Make sure you brush up on EU regulations and guidelines relevant to the pharmaceutical industry. Being able to discuss specific regulations and how they apply to the role will show that you're not just familiar with the basics, but that you’re ready to dive into the nitty-gritty.
✨Showcase Your Organisational Skills
Prepare examples of how you've managed multiple projects or adapted to changing priorities in your previous roles. This is crucial for a Regulatory Affairs Liaison, so having concrete examples will help demonstrate your capability to handle the demands of the job.
✨Communicate Effectively
Since you'll be liaising with cross-functional teams and regulatory agencies, practice articulating your thoughts clearly and concisely. Consider doing mock interviews with a friend to refine your communication skills, especially in explaining complex regulatory concepts.
✨Be Ready to Discuss Risk Management
Think about past experiences where you identified regulatory risks and how you addressed them. Be prepared to discuss these scenarios in detail, as this will highlight your proactive approach and understanding of regulatory strategy development.