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- Tasks: Lead regulatory strategies for biologic products and ensure compliance throughout their lifecycle.
- Company: Join Northreach, a vibrant recruitment agency connecting talent with innovative companies in healthcare and tech.
- Benefits: Enjoy a dynamic work environment that promotes equality, innovation, and professional growth.
- Why this job: Be at the forefront of patient access to essential medicines while collaborating with top industry experts.
- Qualifications: Degree in Life Sciences and extensive experience in European pharmaceutical regulations required.
- Other info: Opportunity to work globally with occasional travel; budget responsibility included.
The predicted salary is between 72000 - 108000 £ per year.
Northreach is a dynamic recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.
We have partnered with a rapidly growing specialty pharmaceutical company dedicated to ensuring patient access to essential medicines worldwide. With a strong presence in the US, UK, and EU, they focus on acquiring, developing, and optimizing specialty and niche medicines—especially in areas where patients rely on continued availability.
As the Director of Regulatory Affairs, you will lead and execute regulatory strategies for biologic products, ensuring compliance throughout development and lifecycle management. You’ll collaborate with internal teams and external partners to drive regulatory success.
- Regulatory Leadership: Act as the subject matter expert for all regulatory aspects of biologic products.
- Strategy & Coordination: Set priorities and work with Regulatory Affairs consultants, Quality, Manufacturing, MSAT, Pharmacovigilance, and Medical Affairs teams to ensure smooth submissions and approvals.
- Product Acquisitions & Development: Oversee regulatory aspects of new biologic acquisitions, including Marketing Authorisation (MA) transfers and new product submissions.
- Authority Engagement: Foster positive relationships with regulatory bodies (MHRA, EMA, FDA) to facilitate approvals.
- Submission Oversight: Ensure high-quality, compliant regulatory submissions aligned with business needs.
- Change Management: Review and manage regulatory change controls related to marketing authorisations.
- Compliance & Communication: Provide regulatory guidance on applications, scientific discussions, and compliance matters.
- Process Improvement: Develop and maintain regulatory standard operating procedures.
- Clinical Trials: Support regulatory aspects of clinical trials and oversee registrations in relevant regions.
- Regulatory Knowledge: Stay up to date with evolving regulations and ensure teams are well-informed and trained.
- Business Alignment: Ensure regulatory strategies align with company objectives.
Role Scope
- Team size: 2
- Regions covered: US, UK, EU, and global
- Budget responsibility: Yes
- Travel requirement: Occasional
Qualifications & Experience
- Education: Degree or higher qualification in Life Sciences.
- Tech Skills: Proficiency in Microsoft Office and strong IT skills.
- Regulatory Expertise: Extensive experience in European pharmaceutical regulations, with familiarity in US requirements.
- Biologic Product Knowledge: Proven track record in leading biologics from development to successful registration.
- Scientific Expertise: Experience in leading scientific advice for biologic products.
If you’ve got what it takes and are on the lookout for a new exciting challenge, then look no further. Apply with an up to date copy of your CV and let’s chat.
Regulatory Affairs Director - Biologics employer: Northreach
Contact Detail:
Northreach Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Director - Biologics
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with biologics. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the sector.
✨Tip Number 2
Familiarise yourself with the specific regulatory bodies relevant to the role, such as the MHRA, EMA, and FDA. Understanding their processes and recent changes in regulations can give you an edge during discussions and interviews.
✨Tip Number 3
Prepare to discuss your previous experiences with biologic products in detail. Be ready to share specific examples of how you've successfully navigated regulatory challenges and led teams through the submission process.
✨Tip Number 4
Showcase your leadership skills by highlighting instances where you've coordinated cross-functional teams. Emphasising your ability to align regulatory strategies with business objectives will demonstrate your fit for the Director role.
We think you need these skills to ace Regulatory Affairs Director - Biologics
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and qualifications required for the Regulatory Affairs Director position. Tailor your application to highlight relevant experiences that align with the job description.
Craft a Tailored CV: Your CV should reflect your extensive experience in regulatory affairs, particularly with biologic products. Emphasise your leadership roles, regulatory submissions, and any successful interactions with regulatory bodies like MHRA, EMA, and FDA.
Write a Compelling Cover Letter: In your cover letter, express your passion for the role and the company. Highlight specific achievements in regulatory affairs and how they relate to the responsibilities outlined in the job description. Make it personal and engaging.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Northreach
✨Showcase Your Regulatory Expertise
Be prepared to discuss your extensive experience with European pharmaceutical regulations and any familiarity you have with US requirements. Highlight specific examples of biologic products you've led from development to registration.
✨Demonstrate Leadership Skills
As a Director, you'll need to exhibit strong leadership qualities. Prepare to share instances where you've successfully coordinated teams across various departments, such as Quality, Manufacturing, and Medical Affairs, to achieve regulatory success.
✨Engage with Authority Knowledge
Familiarise yourself with the regulatory bodies relevant to the role, such as the MHRA, EMA, and FDA. Be ready to discuss how you've fostered positive relationships with these authorities in past roles to facilitate approvals.
✨Emphasise Process Improvement
Discuss your experience in developing and maintaining regulatory standard operating procedures. Share examples of how you've implemented process improvements that have led to more efficient regulatory submissions and compliance.
