Associate Director, Global Regulatory Strategy
Associate Director, Global Regulatory Strategy

Associate Director, Global Regulatory Strategy

Hatfield Full-Time 43200 - 72000 £ / year (est.) No home office possible
Eisai EMEA

At a Glance

  • Tasks: Lead regulatory strategies for innovative Neurology products and improve development processes.
  • Company: Join Eisai, a leading pharmaceutical company focused on patient-first healthcare.
  • Benefits: Competitive salary, hybrid working, well-being programmes, and learning opportunities.
  • Why this job: Make a real impact in healthcare while working with diverse teams and cutting-edge projects.
  • Qualifications: Life Sciences degree with extensive regulatory experience and strong leadership skills.
  • Other info: Inclusive environment with excellent career growth and a commitment to diversity.

The predicted salary is between 43200 - 72000 £ 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 & mental health awareness programmes
  • Multi-faith prayer room

You will also be based out of our excellent EMEA Knowledge Centre (EKC) facility, which is our EU Headquarters, and offers an inclusive, and collaborative working environment.

What you need to do next

If you are interested in this position, please click ‘apply now’ at the top of this advert. Upon submitting your application, you will be asked to complete your profile and upload a copy of your CV along with any additional information to support your application.

If you have any questions, please contact us on TalentAcquisition@eisai.net.

Eisai Recruitment Statement

Diverse perspectives and experiences are critical to our success, and we welcome applications from all people from all backgrounds with the experience and skills needed to perform this role. We look forward to receiving your application.

We believe that diverse and inclusive teams promote wellbeing, learning and innovation, helping Eisai serve our patients, their families, our employees, and society. Our commitment is:

  • to embrace and celebrate our differences, respecting and valuing each other.
  • to include equity, diversity, and inclusion practices in all that we do so everyone has a full sense of belonging.
  • to value individual talent where every employee can be themselves and thrive in an environment of openness, trust, and integrity.

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Associate Director, Global Regulatory Strategy employer: Eisai EMEA

Eisai is an exceptional employer that prioritises a human healthcare philosophy, ensuring that patient needs are at the forefront of our operations. With a competitive salary and a comprehensive benefits package, including hybrid working options and extensive learning and development opportunities, we foster a collaborative and inclusive work culture at our EMEA Knowledge Centre. Employees can thrive in an environment that values diversity, promotes well-being, and encourages professional growth, making Eisai a rewarding place to advance your career in regulatory affairs.
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 people in the industry, especially those who work at Eisai or similar companies. A friendly chat can open doors and give you insider info that could help you stand out.

✨Tip Number 2

Prepare for interviews by researching the company’s values and recent projects. Show us that you’re not just another candidate; demonstrate how your experience aligns with Eisai's human healthcare philosophy.

✨Tip Number 3

Practice your pitch! Be ready to explain how your background in regulatory affairs makes you the perfect fit for the Associate Director role. Keep it concise but impactful—make us remember you!

✨Tip Number 4

Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows us you’re genuinely interested in joining our team at Eisai.

We think you need these skills to ace Associate Director, Global Regulatory Strategy

Regulatory Affairs
Pharmaceutical Experience
EU Regulatory Knowledge
Scientific Advice
Paediatric Investigational Plans
Regulatory Strategy Development
Global Regulatory Strategies
Team Leadership
Matrix Leadership Skills
Drug Laws and Regulations
Communication Skills
Project Coordination
Analytical Skills
Problem-Solving Skills

Some tips for your application 🫡

Tailor Your CV: Make sure your CV is tailored to the Associate Director role. Highlight your relevant experience in regulatory affairs, especially with EU health authorities like EMA and MHRA. We want to see how your background aligns with our needs!

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 achievements that relate to the role, and let us know why you want to join Eisai.

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, and how you can bring that expertise to our collaborative environment at Eisai.

Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just click 'apply now' and follow the prompts!

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 for Neurology products. Familiarise yourself with the EMA and MHRA processes, as well as any recent changes in drug laws that could impact your role.

✨Showcase Your Leadership Skills

Be prepared to discuss your experience in leading teams and projects. Think of specific examples where you've successfully navigated a matrix environment and how you’ve contributed to regulatory strategies. This will demonstrate your ability to represent Global Regulatory Strategy effectively.

✨Prepare for Scenario Questions

Expect questions that ask how you would handle specific regulatory challenges or improve development cycle timelines. Practise articulating your thought process and decision-making skills in these scenarios to show your strategic thinking.

✨Align with Their Human Healthcare Philosophy

Eisai puts patients first, so be ready to discuss how your regulatory strategies can enhance patient outcomes. Share examples from your past work that highlight your commitment to patient-centric approaches in regulatory affairs.

Associate Director, Global Regulatory Strategy
Eisai EMEA
Location: Hatfield

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