At a Glance
- Tasks: Lead regulatory strategies for innovative Neurology products and improve development processes.
- Company: Join Eisai, a leading pharmaceutical company focused on human healthcare.
- Benefits: Competitive salary, hybrid working, well-being initiatives, and learning opportunities.
- Other info: Opportunity for international travel and collaboration across diverse teams.
- Why this job: Make a real impact in patient care while advancing your career in a dynamic environment.
- Qualifications: Degree in Life Sciences with extensive pharmaceutical and regulatory experience.
The predicted salary is between 63000 - 77000 £ per year.
Associate 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 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 Pharm D/Ph D 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 Well-being
Associate Director, Global Regulatory Strategy - Permanent Position employer: Eisai Europe Limited
Eisai is an exceptional employer that prioritises employee well-being and professional growth, offering a hybrid working model and a range of benefits including a subsidised onsite restaurant and mental health awareness programmes. Our inclusive work culture fosters collaboration and innovation, ensuring that every team member feels valued and empowered to contribute to meaningful clinical trial transparency efforts. Located in a supportive environment, Eisai provides unique opportunities for learning and development, making it an ideal place for those seeking a rewarding career in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Global Regulatory Strategy - Permanent Position
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Eisai Europe Limited.
✨Leverage Internships for Full-time Roles
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We think you need these skills to ace Associate Director, Global Regulatory Strategy - Permanent Position
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 Europe Limited!
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 Europe Limited 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 Europe Limited!
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 Europe Limited, 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 Europe Limited
✨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 Europe Limited 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 Europe Limited’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.
