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- Tasks: Lead global regulatory strategy for Neurology clinical trials and product registrations.
- Company: Join Eisai, a top-tier pharmaceutical company focused on patient-first healthcare.
- Benefits: Enjoy hybrid work, competitive salary, bonuses, and wellness programs.
- Why this job: Make a real impact in healthcare while working in an inclusive and collaborative environment.
- Qualifications: Bachelor's degree with extensive experience in regulatory affairs in biotech/pharma.
- Other info: Work from our state-of-the-art EMEA Knowledge Centre and embrace diversity.
The predicted salary is between 48000 - 72000 £ per year.
Job description:
Director Global Regulatory Affairs – Permanent Position
The Company
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 Director, EMEA Global Regulatory Strategy, directs the development of submission of Neurology clinical trial applications, product registration dossiers, supplements, amendments. Provides strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions.
Interact and negotiate with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures that clinical trial designs meet regulatory requirements. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to project team, developing regulatory strategy for Eisai assets and providing. advice on all aspects of product development from a regulatory perspective. Supports collaboration development with partners.
What are we looking for?
- Bachelor’s degree
- Extensive industry experience with demonstrated experience in direct Regulatory Affairs in the biotech/biopharmaceutical industry.
- Demonstrated track record of interfacing effectively with global regulatory agencies, such as the EMA
- Experience Clinical Trial Applications, including submission and maintenance
- Paediatric Investigation Plan experience preferred but not required
- Strong understanding and practical experience with regulations and guidelines governing pharmaceutical development and registration.
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
- Retail discounts
- 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
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.
Eisai EMEA EDI Commitment Statement
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
Director Global Regulatory Affairs - Permanent Position employer: Eisai
Contact Detail:
Eisai Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Global Regulatory Affairs - Permanent Position
✨Tip Number 1
Familiarize yourself with the specific regulatory agencies relevant to the pharmaceutical industry, especially the EMA. Understanding their processes and requirements can give you a significant edge in discussions and negotiations.
✨Tip Number 2
Network with professionals in the regulatory affairs field. Attend industry conferences or webinars where you can meet people who work at regulatory agencies or in similar roles. Building these connections can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest regulations and guidelines governing pharmaceutical development. Subscribe to relevant journals or newsletters to ensure you are aware of any changes that could impact your role and the company’s strategy.
✨Tip Number 4
Prepare for interviews by practicing how to articulate your experience with clinical trial applications and interactions with regulatory agencies. Be ready to discuss specific examples of how you've successfully navigated regulatory challenges in the past.
We think you need these skills to ace Director Global Regulatory Affairs - Permanent Position
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Director Global Regulatory Affairs position. Understand the key responsibilities and required qualifications, especially the importance of regulatory strategy and interaction with global agencies.
Tailor Your CV: Customize your CV to highlight relevant experience in regulatory affairs, particularly in the biotech/biopharmaceutical industry. Emphasize any direct interactions with regulatory agencies and your track record in clinical trial applications.
Craft a Strong Cover Letter: Write a compelling cover letter that reflects your passion for patient-first healthcare and your strategic vision for regulatory affairs. Mention specific experiences that align with Eisai's values and the requirements of the role.
Prepare for Potential Questions: Anticipate questions related to your experience with regulatory submissions and negotiations. Be ready to discuss how you have successfully navigated regulatory challenges in previous roles.
How to prepare for a job interview at Eisai
✨Understand Regulatory Frameworks
Make sure you have a solid grasp of the regulations and guidelines governing pharmaceutical development and registration. Be prepared to discuss how your experience aligns with these frameworks, especially in relation to the EMA.
✨Showcase Your Experience
Highlight your extensive industry experience in Regulatory Affairs, particularly in the biotech/biopharmaceutical sector. Be ready to provide specific examples of successful interactions with global regulatory agencies and how you expedited approvals.
✨Demonstrate Strategic Thinking
Prepare to discuss your approach to developing regulatory strategies for clinical trial applications and product registrations. Illustrate how you can provide strategic direction to project teams and ensure compliance throughout the product lifecycle.
✨Emphasize Collaboration Skills
Eisai values collaboration, so be sure to highlight your ability to work effectively with cross-functional teams and external partners. Share examples of how you've successfully collaborated on regulatory matters to achieve common goals.
