Director Global Regulatory Strategy - Permanent Position

Director, Global Regulatory Strategy - 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 As a Director, Global Regulatory Strategy, you will direct the development of submission of Neurology clinical trial applications, product registration dossiers, supplements, amendments. Provide 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. Serve as a regulatory liaison on the project team throughout the product lifecycle. Ensure that clinical trial designs meet regulatory requirements. Ensure rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serve 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. Support collaboration development with partners. What are we looking for? 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 [email protected] 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