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- Tasks: Lead regulatory research and intelligence to shape global strategies for drug development.
- Company: Join an innovative biopharma company dedicated to advancing therapies for rare genetic conditions.
- Benefits: Enjoy a hybrid work model with flexible remote options and a collaborative culture.
- Why this job: Be part of a mission-driven team making a real impact in the biopharma industry.
- Qualifications: Experience in Regulatory Intelligence and drug development is essential; adaptability is key.
- Other info: This is a temporary maternity cover role, offering unique insights into regulatory affairs.
The predicted salary is between 36000 - 60000 £ per year.
This innovative biopharma company is focused on advancing therapies for individuals living with rare and serious genetic conditions. With operations spanning North America and EMEA, the organisation is recognised for its commitment to scientific excellence and a collaborative, mission-driven culture.
The Associate Director of Regulatory Research & Intelligence will be a key contributor to the development of global regulatory strategies. This role involves gathering and analysing regulatory data to support decision-making for both US and EU development programs. The position is central to ensuring that regulatory pathways, precedents, and trends are effectively leveraged to guide product development.
Core Responsibilities- Perform comprehensive regulatory intelligence searches using public databases, agency websites, and databases.
- Monitor and interpret updates from FDA and EMA, including new proposals, approvals, and regulatory shifts.
- Identify and synthesise relevant clinical trial, labelling, and approval precedents to inform strategic planning.
- Collaborate closely with Global and US Regulatory Leads, as well as cross-functional teams, particularly on EMEA-focused initiatives.
- Deliver insights that shape regulatory approaches across a broad and dynamic development portfolio.
- Deep experience in Regulatory Intelligence within the pharmaceutical or biotech sector.
- Strong background in drug development and the formulation of regulatory strategies across various therapeutic areas.
- Demonstrated expertise in regulatory intelligence, including the use of specialised tools such as Cortellis.
- Comfortable working across time zones, especially with teams based on the US West Coast.
- Adaptable, proactive, and confident in navigating evolving priorities.
This role is part of a small, focused Regulatory Research group embedded within the broader Regulatory Affairs function. The position offers opportunities to engage with Clinical Development and Asset Teams, particularly on topics relevant to the EU region.
Please forward your CV or reach out to Julia Bowden for a confidential discussion about this role and your career.
AD Regulatory Affairs Intelligence 12m Contract employer: Hays
Contact Detail:
Hays Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land AD Regulatory Affairs Intelligence 12m Contract
✨Tip Number 1
Familiarise yourself with the latest regulatory updates from the FDA and EMA. Being well-versed in current trends and changes will not only help you in interviews but also demonstrate your proactive approach to staying informed in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience in biopharma. Engaging with industry experts can provide valuable insights and potentially lead to referrals that could enhance your application.
✨Tip Number 3
Showcase your experience with regulatory intelligence tools like Cortellis during discussions. Highlighting your familiarity with these specialised tools can set you apart as a candidate who is ready to hit the ground running.
✨Tip Number 4
Prepare to discuss your adaptability and experience working across time zones. Given the hybrid nature of the role and collaboration with US teams, demonstrating your ability to manage diverse schedules will be crucial.
We think you need these skills to ace AD Regulatory Affairs Intelligence 12m Contract
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Associate Director - Regulatory Research & Intelligence position. Tailor your application to highlight your relevant experience in regulatory intelligence and drug development.
Highlight Relevant Experience: In your CV and cover letter, emphasise your deep experience in Regulatory Intelligence within the pharmaceutical or biotech sector. Provide specific examples of how you've contributed to regulatory strategies and decision-making processes.
Showcase Your Skills: Mention any specialised tools you are familiar with, such as Cortellis, and demonstrate your ability to work across time zones. Highlight your adaptability and proactive approach to navigating evolving priorities in your application.
Craft a Compelling Cover Letter: Write a cover letter that not only summarises your qualifications but also conveys your passion for advancing therapies for individuals with rare genetic conditions. Make it clear why you want to join this innovative biopharma company and how you can contribute to their mission.
How to prepare for a job interview at Hays
✨Know Your Regulatory Landscape
Familiarise yourself with the latest updates from the FDA and EMA. Being able to discuss recent regulatory shifts or proposals will demonstrate your proactive approach and deep understanding of the field.
✨Showcase Your Analytical Skills
Prepare to discuss specific examples where you've gathered and analysed regulatory data. Highlight how your insights have influenced strategic decisions in previous roles, particularly in drug development.
✨Emphasise Collaboration Experience
This role involves working closely with various teams. Be ready to share experiences where you successfully collaborated with cross-functional teams, especially in a global context, to achieve regulatory objectives.
✨Demonstrate Adaptability
Given the dynamic nature of regulatory affairs, illustrate your ability to adapt to changing priorities. Share instances where you've navigated challenges effectively, showcasing your proactive mindset.
