At a Glance
- Tasks: Lead global regulatory strategy for innovative pharmaceutical products and ensure timely approvals.
- Company: Join Eisai, a leading research-based pharmaceutical company focused on patient-first healthcare.
- Benefits: Enjoy competitive salary, hybrid working, well-being programmes, and learning opportunities.
- Other info: Work in an inclusive environment at our EMEA Knowledge Centre with excellent career growth.
- Why this job: Make a real impact in healthcare by guiding drug approvals and collaborating with global teams.
- Qualifications: Extensive regulatory affairs experience in biotech/pharmaceuticals and strong communication skills.
The predicted salary is between 51750 - 63250 £ 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.
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 answer 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 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 with 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:
- Competitive salary and excellent wider benefits package.
- 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.
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.
Director Global Regulatory Strategy - Permanent Position in Hatfield employer: Eisai Pharma AG
Eisai is an exceptional employer that prioritises employee development and fosters a collaborative work culture in the UK. With a commitment to continuous improvement and compliance, employees are empowered to lead teams and make impactful contributions to patient safety. The competitive benefits package and focus on professional growth make Eisai a rewarding place to build a meaningful career in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Director Global Regulatory Strategy - Permanent Position in Hatfield
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If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Eisai Pharma AG. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
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We think you need these skills to ace Director Global Regulatory Strategy - Permanent Position in Hatfield
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Eisai Pharma AG!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Eisai Pharma AG that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Eisai Pharma AG!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Eisai Pharma AG, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Eisai Pharma AG
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Eisai Pharma AG that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Eisai Pharma AG’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
