CT19

www.ct-19.co.uk

1 Job

10 Employees

About the Company

We aim to positively impact people's lives by connecting talent with opportunity through a well-managed, ethical recruitment process.

Initially working within biotechnology and medical technology, we are now partnering with 'Tech For Good' companies across The UK, EU & US.

Listed Jobs

Company Name: CT19
Job Title: Director of Regulatory Affairs
Job Description: **Job Title** Director of Regulatory Affairs – EU **Role Summary** Lead EU regulatory strategy and MAA filings for rare disease biologics, spanning early and late‑phase development through commercialization. Own lifecycle management, ensuring regulatory compliance and enabling successful product launches. **Expectations** - Deliver high‑quality MAAs to EMA (and MHRA, Swiss Medic) for new indications. - Provide strategic regulatory guidance on orphan and first‑in‑class programs. - Operate in a fast‑paced biotech environment, adapting to pipeline changes. **Key Responsibilities** - Develop regulatory strategy for preclinical to commercial phases across multiple indications. - Prepare and submit MAAs, including technical, clinical, and quality dossiers, to EMA, MHRA, and Swiss Medic. - Coordinate cross‑functional teams (clinical, QC, commercial, IP) to meet regulatory milestones. - Monitor EU regulatory developments and assess their impact on the pipeline. - Advise on orphan drug designation, best‑in‑class status, and lifecycle management. - Liaise with EU authorities, facilitate inspections and consultations. - Support launch and post‑marketing activities through regulatory oversight. **Required Skills** - In‑depth knowledge of EMA, MHRA, Swiss Medic pathways; orphan drug and first‑in‑class experience. - Proven MAA submission and lifecycle management experience. - Strategic thinking with hands‑on execution capability. - Strong communication, stakeholder management, and cross‑functional collaboration. - Analytical problem‑solving skills. - Adaptability to a dynamic, demand‑driven biotech setting. **Required Education & Certifications** - Bachelor’s or Master’s in Life Sciences, Pharmacy, Biomedical Sciences, or Regulatory Affairs. - Professional certification in Regulatory Affairs (e.g., RAPS, RA) preferred. ---

Belgium

Remote

28-11-2025