Regulatory Affairs Director - Biologics

Job Description 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...