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- Tasks: Lead regulatory strategies for innovative Neurology products and improve development processes.
- Company: Eisai, a leading research-based pharmaceutical company prioritising patient health.
- Benefits: Competitive salary, hybrid working, learning opportunities, and well-being support.
- Why this job: Make a real impact in healthcare while developing your career in a dynamic environment.
- Qualifications: Degree in Life Sciences with extensive pharmaceutical and regulatory experience.
- Other info: Opportunity for international travel and collaboration across diverse teams.
The predicted salary is between 70000 - 90000 £ per year.
Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology and Pain therapy areas. By joining Eisai, you will be working for an organisation with a human healthcare philosophy, which means that we put the patient first in everything we do.
Your new role
The Associate Director, Regulatory Affairs will be responsible for providing all aspects of regulatory support for products within the Neurology portfolio (development and post-approval). The Associate Director will hold either an EU Regulatory Lead role or Global Regulatory Lead role (or both) depending on the portfolio of products assigned. This person may participate in departmental work streams designed to improve development cycle timelines or to improve regulatory processes. Travel percentage: Approximately 20‑30%, domestic and internationally.
What are we looking for?
- BS/BA degree in Life Sciences in a relevant field with extensive demonstration of broad pharmaceutical experience, including new drug regulated product strategy/submissions; or a Master's or PharmD/PhD degree with extensive demonstration of pharmaceutical experience and related Regulatory experience, including fellowship experience.
- Experience interacting with the EMA, MHRA and other European health authorities.
- Experience with Scientific Advice and Paediatric Investigational Plans.
- Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document.
- Experience developing global regulatory strategies in coordination with clinical plans and marketing objectives.
- Experience in successfully leading teams and the ability to broadly represent Global Regulatory Strategy on project teams.
- Demonstrated matrix leadership skills and the ability to work effectively in a matrix team across multiple disciplines.
- Working knowledge of relevant drug laws, regulations and guidance's/guidelines.
What we offer in return
Eisai offers a competitive salary and excellent wider benefits package that includes:
- Hybrid working (Depending on role)
- Car/Car Allowance (Depending on role)
- Electric charging points for Electric/Hybrid vehicles
- Discretionary Bonus
- Free onsite parking
- Subsidised onsite restaurant and coffee shop
- Learning and development opportunities
- Well‑being
Associate Director, Global Regulatory Strategy employer: Eisai EMEA
Contact Detail:
Eisai EMEA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Global Regulatory Strategy
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those who have experience with EMA and MHRA. A friendly chat can lead to valuable insights and even job leads.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of drug laws and regulations. Be ready to discuss how you've successfully led teams and developed regulatory strategies in the past. Confidence is key!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values, like Eisai’s human healthcare philosophy. Tailor your approach to show how you can contribute to their mission.
✨Tip Number 4
Use our website to apply directly! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining the team at Eisai.
We think you need these skills to ace Associate Director, Global Regulatory Strategy
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Director role. Highlight your experience in regulatory affairs, especially with EU health authorities like the EMA and MHRA. We want to see how your background aligns with our focus on patient-first healthcare.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory strategy in the pharmaceutical industry. Share specific examples of your past successes and how they relate to the role at Eisai. We love a good story!
Showcase Your Leadership Skills: Since this role involves leading teams, make sure to highlight your leadership experience. Talk about how you've successfully managed projects or teams in the past. We’re looking for someone who can effectively represent Global Regulatory Strategy across disciplines.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at Eisai EMEA
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of EU regulations and the specific requirements of the EMA and MHRA. Being able to discuss recent changes in regulatory guidelines or share insights from your past experiences will show that you're not just familiar with the basics, but that you’re genuinely engaged with the field.
✨Showcase Your Leadership Skills
As an Associate Director, you'll need to demonstrate strong leadership abilities. Prepare examples of how you've successfully led teams in the past, especially in a matrix environment. Highlight any experiences where you’ve influenced cross-functional teams or improved processes, as this will resonate well with their expectations.
✨Prepare for Scenario Questions
Expect to face scenario-based questions that assess your problem-solving skills and strategic thinking. Think about challenges you've encountered in regulatory affairs and how you overcame them. This will help you articulate your thought process and decision-making skills during the interview.
✨Align with Their Human Healthcare Philosophy
Eisai places a strong emphasis on patient-first approaches. Be ready to discuss how your values align with this philosophy. Share examples of how you've prioritised patient outcomes in your previous roles, as this will demonstrate that you understand and appreciate their core mission.