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- Tasks: Lead regulatory strategies for biologic products and ensure compliance throughout their lifecycle.
- Company: Join a fast-growing specialty pharmaceutical company focused on patient access to essential medicines worldwide.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and innovation.
- Why this job: Be at the forefront of biologics, making a real impact on patient care and access to medicines.
- Qualifications: Degree in Life Sciences and extensive experience in European pharmaceutical regulations required.
- Other info: Occasional travel may be needed; team size is small, fostering close collaboration.
The predicted salary is between 48000 - 84000 £ 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.
Key Responsibilities:- 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.
- Team size: 2
- Regions covered: US, UK, EU, and global
- Budget responsibility: Yes
- Travel requirement: Occasional
- 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 in leading biologics through the regulatory process. Be ready to share specific examples of successful submissions or strategies you've implemented that align with the responsibilities outlined in the job description.
✨Tip Number 4
Showcase your leadership skills by highlighting any experience you have in managing teams or projects. Emphasising your ability to coordinate with various departments will demonstrate your capability to fulfil the role's requirements effectively.
We think you need these skills to ace Regulatory Affairs Director - Biologics
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Regulatory Affairs Director position. Tailor your application to highlight your relevant experience in regulatory strategies for biologic products.
Craft a Strong CV: Your CV should clearly outline your educational background, particularly in Life Sciences, and your extensive experience with European and US pharmaceutical regulations. Emphasise your proven track record in leading biologics from development to registration.
Write a Compelling Cover Letter: In your cover letter, express your passion for ensuring patient access to essential medicines and your commitment to compliance and regulatory excellence. Mention specific examples of how you've successfully navigated regulatory challenges in the past.
Highlight Relevant Skills: Make sure to showcase your proficiency in Microsoft Office and any other relevant IT skills. Additionally, emphasise your ability to foster relationships with regulatory bodies like MHRA, EMA, and FDA, as this is crucial for the role.
How to prepare for a job interview at Northreach
✨Showcase Your Regulatory Expertise
Make sure to highlight your extensive experience with European pharmaceutical regulations and familiarity with US requirements. Be prepared to discuss specific examples of how you've successfully navigated regulatory challenges in the past.
✨Demonstrate Leadership Skills
As a Director, you'll need to exhibit strong leadership qualities. Prepare to share instances where you've led teams or projects, particularly in the context of biologic products, and how you fostered collaboration across departments.
✨Engage with Authority Engagement Strategies
Since building relationships with regulatory bodies is crucial, think about how you've previously engaged with organisations like the MHRA, EMA, or FDA. Be ready to discuss your approach to fostering these relationships and any successful outcomes.
✨Stay Updated on Regulatory Changes
Show your commitment to staying informed about evolving regulations. Discuss how you keep yourself and your team updated on changes in the regulatory landscape and how this knowledge has influenced your strategic decisions.
