Regulatory Affairs Director - Biologics

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 an rapidly growing fast-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.

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.