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- Tasks: Lead and manage interactions with the European Medicines Agency (EMA) for drug development.
- Company: Medpace is a top CRO for Biotech, growing year-over-year.
- Benefits: Enjoy a full-time role with minimal travel and a dynamic work environment.
- Why this job: Join a team that shapes global drug strategies and impacts patient care.
- Qualifications: MD, PhD, or advanced degree with 5+ years in regulatory drug development.
- Other info: Expertise with EMA and strategic leadership skills are essential.
The predicted salary is between 72000 - 108000 £ per year.
Medpace is the leading CRO for Biotech companies that has continued its growth year-over-year. We are currently seeking a full-time office based Director / Associate Director, Regulatory Affairs to join our team. This position will lead & manage interactions with the European Medicines Agency (EMA) and provide strategic input into the global drug development plans of our clients. The ideal candidate possesses strategic leadership skills, has deep experience interacting with the EMA, and expert knowledge of global drug development processes and strategies.
Responsibilities
- Provide expert regulatory strategy to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures, and agency precedent;
- Advise project teams regarding the development and implementation of regulatory strategy throughout the clinical development processes;
- Collaborate across development teams on strategic projects including gap analyses, meetings with regulatory authorities, protocol synopsis development and review, and other strategic deliverables;
- Maintain advanced knowledge of changing regulatory requirements and advise teams as appropriate; Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
- Interact with the appropriate national/regional government regulatory agencies;
- Provide regulatory advice and guidance to Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics.
Qualifications
- MD, PhD in Life Sciences, or other advanced degree;
- Minimum of 5 years of experience or equivalent in regulatory drug development. Expert knowledge of regulatory affairs within one or more therapeutic areas;
- Professional experience working at the EMA such as within a scientific committee, preferred;
- Extensive experience working/partnering with the EMA required.
Travel: Less than 10%.#J-18808-Ljbffr
Associate Director/Director - Regulatory Affairs (EMA expert) employer: Medpace
Contact Detail:
Medpace Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director/Director - Regulatory Affairs (EMA expert)
✨Tip Number 1
Make sure to highlight your experience with the European Medicines Agency (EMA) in your conversations. Discuss specific projects or interactions you've had that demonstrate your expertise and strategic leadership skills.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have worked with the EMA. Attend industry conferences or webinars where you can connect with potential colleagues and learn more about current trends and challenges.
✨Tip Number 3
Stay updated on the latest regulatory changes and guidelines from the EMA. Being knowledgeable about recent developments will not only help you in discussions but also show your commitment to the field.
✨Tip Number 4
Prepare to discuss how you can provide strategic input into global drug development plans. Think of examples where your regulatory strategy has positively impacted a project and be ready to share these insights during your interactions.
We think you need these skills to ace Associate Director/Director - Regulatory Affairs (EMA expert)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in regulatory affairs, especially any direct interactions with the European Medicines Agency (EMA). Emphasize your strategic leadership skills and any specific projects that demonstrate your expertise in global drug development.
Craft a Strong Cover Letter: In your cover letter, clearly articulate your motivation for applying to Medpace and how your background aligns with the responsibilities of the role. Mention specific experiences where you provided regulatory strategy or collaborated with cross-functional teams.
Highlight Relevant Qualifications: Ensure you explicitly mention your MD, PhD, or other advanced degrees in Life Sciences, along with your years of experience in regulatory drug development. If you have worked at the EMA or have experience with scientific committees, make this a focal point.
Showcase Continuous Learning: Demonstrate your commitment to staying updated on changing regulatory requirements. Mention any recent training, certifications, or workshops related to regulatory affairs that you have completed.
How to prepare for a job interview at Medpace
✨Showcase Your EMA Experience
Make sure to highlight your previous interactions with the European Medicines Agency. Discuss specific projects or experiences where you successfully navigated regulatory challenges, as this will demonstrate your expertise and familiarity with their processes.
✨Demonstrate Strategic Leadership Skills
Prepare examples that showcase your strategic leadership abilities. Talk about how you've led teams in developing regulatory strategies and how your input has influenced global drug development plans.
✨Stay Updated on Regulatory Changes
Be ready to discuss recent changes in regulatory requirements and how they might impact drug development. This shows that you are proactive and knowledgeable about the evolving landscape of regulatory affairs.
✨Collaborative Mindset
Emphasize your ability to collaborate across various teams. Provide examples of how you've worked with Clinical Operations, Medical Writing, and other departments to achieve regulatory goals, as teamwork is crucial in this role.
