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- Tasks: Lead global regulatory strategy for innovative immunotherapeutic products and manage regulatory documents.
- Company: Join Barinthus Biotherapeutics, a pioneering company reshaping healthcare with cutting-edge solutions.
- Benefits: Enjoy flexible working, pension plans, healthcare, and share options to secure your future.
- Why this job: Be part of a dynamic team making a real impact in the fight against chronic diseases.
- Qualifications: Expertise in biologics regulation and experience with global regulatory requirements are essential.
- Other info: This hybrid role offers 3 days onsite and 2 days remote work each week.
The predicted salary is between 80000 - 120000 £ per year.
Barinthus Biotherapeutics is on a quest for a Senior Director or Director of Regulatory Affairs Strategy who is not just looking for a job, but a calling. With us, you’ll embark on a journey of discovery, guiding the immune system to conquer chronic diseases, autoimmunity, and cancer.
What’s in it for you?
- Be a Trailblazer: Be part of a rapidly growing business that’s reshaping the healthcare landscape.
- Flexible Work-Life Balance: Enjoy our flexible working policy, with the option to work from home for up to two days per week.
- Empowering Benefits: From pension plans to healthcare, and share options, we invest in your future.
- Innovative Culture: Work in an environment that values Leading By Example, is Team Focused, Acting With Impact, and upholds Trust and Respect all to Deliver Excellence.
What you’ll be doing:
- Strategize for Success: Lead the global regulatory strategy for our cutting-edge immunotherapeutic products.
- Drive Regulatory Excellence: Manage strategic regulatory documents and interactions with global agencies.
- Collaborate for Impact: Align regulatory strategies with product development plans, working with diverse teams.
Essential skills and requirements:
- Biologics Regulation Expertise: Experience in the regulation of biologics, including immunomodulating therapies and vaccines, is highly valued.
- Product Development Insight: In-depth experience with clinical and non-clinical regulatory aspects of products in development.
- Global Regulatory Knowledge: Strong experience with biologics registration requirements in Europe and familiarity with international regulations (UK MHRA essential, US FDA preferred).
- Regulatory Lifecycle Proficiency: Solid understanding of Regulatory Life Cycle Management and eCTD format for regulatory filings.
- Submission Mastery: Demonstrated ability in drafting and organizing regulatory submissions, amendments, and supplements.
The Time to Act is Now! Don’t miss this chance to make a real difference. Apply today and join a team that’s not just part of the industry, but leading it. Barinthus Biotherapeutics is more than a company—it’s a beacon of hope and innovation. Apply now and let’s navigate towards a healthier world together. Barinthus Biotherapeutics awaits your expertise. Are you ready to guide us into the future? Apply now and let your career set sail with us.
Contact Detail:
Barinthus Biotherapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director or Senior Director of Regulatory Affairs Strategy
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with biologics and immunotherapies. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in regulatory strategy.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements for biologics in Europe and the UK. Understanding the nuances of the UK MHRA and EU regulations will give you an edge in discussions during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences in managing regulatory submissions and interactions with global agencies. Be ready to provide examples of how you've successfully navigated complex regulatory landscapes in your past roles.
✨Tip Number 4
Showcase your leadership skills by highlighting instances where you've led cross-functional teams in developing regulatory strategies. Emphasising your ability to collaborate effectively will resonate well with the company's focus on teamwork and impact.
We think you need these skills to ace Director or Senior Director of Regulatory Affairs Strategy
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Director or Senior Director of Regulatory Affairs Strategy position. Tailor your application to highlight relevant experience in biologics regulation and product development.
Craft a Compelling CV: Your CV should clearly showcase your expertise in regulatory affairs, particularly in biologics and immunotherapeutic products. Use specific examples of your past achievements and how they align with the job description.
Write a Strong Cover Letter: In your cover letter, express your passion for the role and the company’s mission. Highlight your strategic vision for regulatory affairs and how your experience can contribute to Barinthus Biotherapeutics' goals.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents. Check for any grammatical errors or typos, and ensure that your application is polished and professional.
How to prepare for a job interview at Barinthus Biotherapeutics
✨Showcase Your Regulatory Expertise
Make sure to highlight your experience with biologics regulation, especially in immunomodulating therapies and vaccines. Be prepared to discuss specific examples of how you've navigated complex regulatory landscapes.
✨Demonstrate Strategic Thinking
Prepare to articulate your approach to developing global regulatory strategies. Discuss how you align these strategies with product development plans and the impact of your decisions on project outcomes.
✨Familiarise Yourself with Company Culture
Research Barinthus Biotherapeutics' values such as Leading By Example and Team Focus. Be ready to share how your personal values align with theirs and how you can contribute to their innovative culture.
✨Prepare for Collaborative Scenarios
Expect questions about teamwork and collaboration. Think of examples where you've successfully worked with diverse teams to achieve regulatory goals, and be ready to discuss the challenges and solutions you encountered.
