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- Tasks: Lead global regulatory strategies and submissions for innovative therapies in a dynamic environment.
- Company: Immunocore, a pioneering biotech company focused on transformative medicines.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Why this job: Make a real impact in drug development and work with cutting-edge science.
- Qualifications: Experience in regulatory affairs and strong leadership skills required.
- Other info: Join a diverse team dedicated to advancing medicine and improving patient lives.
The predicted salary is between 130000 - 220000 £ per year.
Location of role: Radnor, PA, Gaithersburg, MD, Oxford, UK
Department: Regulatory Affairs
Key Responsibilities:
- The Director of Regulatory Affairs will be responsible for assigned projects and all of the regulatory affairs activities by providing expertise to Immunocore's development programs.
- Regulatory scientific and tactical strategy development, IND development/submission/maintenance, BLA/sBLA development/submission/maintenance, agency liaison and regulatory intelligence.
- Interacting with global sites, both in-house and outsourced.
- Establishing a successful relationship with the FDA and overseeing submissions to the EMA, MHRA, and other local Health Authorities.
- Providing regulatory leadership and support to cross-functional development project teams.
- Developing regulatory scientific and tactical strategic plans, and target labelling to support product development.
- Managing, preparing, co-ordinating and being responsible for the submission of documentation supporting regulatory submissions.
- Being the center of excellence for all regulatory requirements and guidelines globally.
- Contributing to the establishment and development of procedures and working practices.
- Overseeing regulatory review of clinical trial labelling and CMC submissions for regulatory compliance.
- Demonstrating professionalism, efficiency, and leadership within the team.
- Reviewing and ensuring the quality of detailed scientific and technical information.
Supervisory Responsibility:
This position does not initially have direct reports but may in the future.
Competencies:
- Communication Proficiency
- Time Management
- Collaboration Skills
- Personal Effectiveness/Credibility
- Flexibility
- Technical Capacity
- Stress Management/Composure
Immunocore Values:
- We lead with science to benefit patients
- We are entrepreneurial
- We value diversity to drive innovation
- We respect each other and act with integrity
- We do the right thing
Person Specification:
Experience & Knowledge:
- Solid track record in drug development and leadership within dynamic project teams.
- Strong understanding of global regulatory requirements.
- Excellent knowledge of US regulatory requirements and extensive experience with submissions.
- Experience in supporting global clinical studies.
- Experience in managing, preparing, submitting INDs/CTAs, BLAs/NDAs, and MAAs.
- Experience in preparing for, and conducting Health Authority Meetings.
- Demonstrate ability to be agile to accommodate changing priorities.
- Proven leadership, excellent communication and interpersonal skills.
Education & Qualifications:
Advanced degree preferred – M.S., PharmD, Ph.D., or M.D. with 5-10 years' experience or BS with 8-12 years' experience.
Position Type & Expected Hours of Work / Travel:
This is a Full Time, Exempt position. Occasional overtime may be required based on work priorities. Limited overnight travel is expected for this position.
US Salary Range: $157,500- $262,500
About the Company:
Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize transformative medicines addressing unmet patient needs in oncology, infectious diseases, and autoimmune disease.
Immunocore is proud to be an equal opportunity employer, committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered.
Director, Regulatory Affairs-Global Regulatory Lead employer: Immunocore
Contact Detail:
Immunocore Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Regulatory Affairs-Global Regulatory Lead
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with yours. We want to see you shine, so practice common interview questions and have your own ready to ask. Show them you’re genuinely interested!
✨Tip Number 3
Follow up after interviews! A simple thank-you email can go a long way. It shows your appreciation and keeps you on their radar. We recommend mentioning something specific from the interview to remind them of your conversation.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive and take the initiative to connect directly with us.
We think you need these skills to ace Director, Regulatory Affairs-Global Regulatory Lead
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Director, Regulatory Affairs role. Highlight your experience in drug development and regulatory submissions, especially in biologics, to show us you’re the right fit.
Showcase Your Leadership Skills: We want to see how you've led teams and projects in the past. Share specific examples of how you've developed regulatory strategies or managed submissions to health authorities like the FDA or EMA.
Be Clear and Concise: When writing your application, clarity is key! Use straightforward language and structure your documents well. We appreciate a well-organised submission that makes it easy for us to see your qualifications.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for this exciting opportunity at Immunocore.
How to prepare for a job interview at Immunocore
✨Know Your Regulatory Stuff
Make sure you brush up on the latest global regulatory requirements, especially those related to biologics and oncology. Familiarise yourself with the nuances of INDs, BLAs, and CTAs, as well as the specific guidelines from the FDA and EMA. This knowledge will not only help you answer questions confidently but also demonstrate your expertise in the field.
✨Showcase Your Leadership Skills
Since this role requires strong leadership within cross-functional teams, be prepared to share examples of how you've successfully led projects in the past. Highlight your ability to collaborate effectively and manage diverse teams under pressure. Use specific instances where your leadership made a significant impact on project outcomes.
✨Prepare for Health Authority Meetings
Given the importance of liaising with health authorities, it’s crucial to discuss your experience in preparing for and conducting meetings with them. Be ready to talk about how you’ve built relationships with agencies like the FDA and how you’ve navigated challenging discussions. This will show that you can handle high-stakes interactions with confidence.
✨Demonstrate Agility and Problem-Solving
In a fast-paced environment, being agile is key. Prepare to discuss times when you had to adapt quickly to changing priorities or solve unexpected problems. Share how you approached these challenges and what the outcomes were. This will illustrate your ability to thrive in an entrepreneurial setting, which is essential for this role.