Director Global Regulatory Strategy

Eisai EMEA; Hatfield; Hybrid; GBP 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid working (depending on role)

Car/Car Allowance (depending on role)

Electric charging points for EVs

Discretionary Bonus

Free onsite parking

Learning and development opportunities

Well-being & mental health programmes

Job summary

Eisai EMEA is seeking a Director of Global Regulatory Strategy to steer the submission of Neurology trial applications, registration dossiers and amendments. You will guide regulatory interactions with agencies to accelerate approvals and serve as a regulatory liaison across project teams throughout the product lifecycle.

The role requires extensive regulatory affairs experience, strong EMA engagement skills, and the ability to shape global regulatory strategy while supporting collaborations.

Qualifications

• Extensive industry experience in regulatory affairs within biotech/biopharmaceuticals.
• Direct experience interfacing with global regulatory agencies (EMA).
• Experience with Clinical Trial Applications, submissions and maintenance.
• Strong understanding of pharmaceutical development and registration regulations.
• Experience leading regulatory strategy across product lifecycles.
• Paediatric Investigation Plan experience is a plus but not required.

Responsibilities

• Direct the development and submission of regulatory dossiers, trials and amendments.
• Provide strategic direction to project teams for regulatory interactions with agencies.
• Lead and coordinate EMA and Health Authority dialogues including Scientific Advice.
• Ensure regulatory compliance of trial designs and ongoing approvals across Europe.
• Serve as regulatory liaison throughout product lifecycle and support collaborations.
• Monitor regulatory environment and convey implications to teams.
• Act as potential Global Regulatory Lead for Eisai assets.

Skills

Regulatory affairs

EMA liaison

Clinical trial applications

Regulatory strategy

Cross-functional leadership

Regulatory guidance

Job description

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, 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. Interacts and negotiates 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.

• Identify regulatory requirements and develop optimal regulatory strategies to support the development and maintenance of Eisai products in accordance with corporate objectives.
• Maintain all regulatory aspects of clinical trial activities for products in compliance with the EU Clinical Trial Regulation.
• Act as point of contact with project teams for all regulatory-related activities throughout the lifecycle of a product.
• Ensure submissions critical to the company’s business objectives are compiled and submitted to regulatory authorities within defined time schedules and in accordance with established standards.
• Point of contact with regulatory agencies, including EMA and National Competent Authorities to facilitate the review and approval of clinical trial applications and registration dossiers.
• Lead Scientific Advice interactions with EMA and other Health Authorities, including the preparation and submission of supporting materials.
• Continuously evaluate the constantly changing regulatory environment for impact on assigned projects and development programs.
• Develop regulatory intelligence concerning competitor products and convey to project/core teams.
• Strong interpersonal skills.
• The candidate will have responsibility for regulatory activities within Europe and there is potential for the candidate to act as the Global Regulatory Lead for a product.

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
• 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.

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