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- Tasks: Shape and execute regulatory strategies for innovative therapies in a dynamic environment.
- Company: Join a mission-driven company focused on rare diseases and patient access.
- Benefits: Enjoy competitive pay, generous vacation, and flexible hybrid work options.
- Why this job: Make a real impact on patient-focused innovation while leading regulatory success.
- Qualifications: 8+ years in regulatory affairs with strong knowledge of EMEA regulations.
- Other info: Collaborative culture with opportunities for professional development and wellness support.
The predicted salary is between 36000 - 60000 £ per year.
We are currently looking for an Associate Director Regulatory Affairs in the UK. In this role, you will play a key part in shaping and executing regulatory strategies across the EMEA region for innovative therapies addressing rare diseases. You will operate in a dynamic, science-driven environment, working closely with cross-functional teams to support late-stage development, global clinical trials, and post-marketing activities. Your expertise will directly influence regulatory success, patient access, and long-term product sustainability. This position offers a balance of strategic leadership and hands-on execution within a collaborative and mission-driven setting. You will engage with global and regional stakeholders while navigating complex regulatory frameworks. The role follows a flexible hybrid work model, combining on-site collaboration with autonomy.
Accountabilities:
- Define, contribute to, and execute EMEA regulatory strategies for assigned products across development and post-marketing phases.
- Provide strategic and technical regulatory guidance to cross-functional development and project teams.
- Review and contribute to regulatory documentation, including major submissions such as INDs, NDAs, BLAs, and MAAs.
- Coordinate and manage regulatory sections of global applications and support label development activities.
- Act as a primary or key liaison with regulatory agencies, including planning, preparing, and leading agency meetings.
- Lead regulatory response processes and track post-marketing commitments and requirements.
- Ensure effective coordination between global and local regulatory partners to meet regional objectives.
Requirements:
- Bachelor’s degree in life sciences or a related field; an advanced degree is preferred.
- Minimum of 8 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
- Strong knowledge of global regulatory frameworks, drug development processes, and post-approval requirements.
- Proven experience with EMEA regulations, including drugs, biologics, and advanced therapy medicinal products.
- Specific regulatory experience related to the GCC region is required.
- Excellent communication, collaboration, and stakeholder management skills.
- Fluency in English; Arabic is a strong advantage.
- Willingness to travel occasionally, generally less than 10 percent.
Benefits:
- Competitive compensation and long-term incentive opportunities.
- Generous vacation allowance and company-observed public holidays.
- Flexible hybrid work model with on-site collaboration days.
- Comprehensive employee wellbeing and healthcare-related benefits.
- Fitness reimbursement and wellness support programs.
- Tuition sponsorship and structured professional development plans.
- Opportunities to contribute to meaningful, patient-focused innovation.
Associate Director Regulatory Affairs employer: Jobgether
Contact Detail:
Jobgether Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to professionals in regulatory affairs on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Associate Director role.
✨Tip Number 2
Prepare for interviews by brushing up on EMEA regulations and recent developments in the field. We recommend practising common interview questions with a friend or mentor to boost your confidence.
✨Tip Number 3
Showcase your hands-on experience! Be ready to discuss specific projects where you’ve influenced regulatory success. We want to hear about your strategic thinking and execution skills.
✨Tip Number 4
Apply through our website for a smoother process! Our AI-powered matching system ensures your application gets the attention it deserves, so let’s get you noticed for that dream job!
We think you need these skills to ace Associate Director Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Director Regulatory Affairs role. Highlight your experience in regulatory affairs, especially within the EMEA region, and showcase any specific achievements that align with the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background makes you a perfect fit for this position. Don’t forget to mention your experience with global regulatory frameworks!
Showcase Your Communication Skills: Since this role involves liaising with various stakeholders, make sure to highlight your communication and collaboration skills in your application. Provide examples of how you've successfully managed relationships in previous roles.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. Our AI-powered system ensures your application gets the attention it deserves, so don’t miss out on this opportunity!
How to prepare for a job interview at Jobgether
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of EMEA regulations and the specific requirements for drugs, biologics, and advanced therapy medicinal products. Being able to discuss these confidently will show that you're not just familiar with the basics but also understand the nuances that can impact regulatory success.
✨Showcase Your Strategic Thinking
Prepare examples of how you've defined and executed regulatory strategies in previous roles. Think about times when your strategic input led to successful outcomes in late-stage development or post-marketing activities. This will demonstrate your ability to think critically and lead effectively in a dynamic environment.
✨Engage with Cross-Functional Teams
Since this role involves working closely with various teams, be ready to discuss how you've collaborated with different stakeholders in the past. Highlight your communication skills and provide examples of how you’ve successfully navigated complex projects by coordinating with diverse groups.
✨Prepare for Agency Interactions
Expect questions about your experience liaising with regulatory agencies. Be prepared to share specific instances where you planned and led agency meetings, as well as how you managed regulatory responses. This will showcase your hands-on experience and ability to handle high-stakes interactions.
