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 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
* 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