Regulator Labelling Senior Consultant

Job Title:

Regulator Labelling Senior Consultant Location:

European Union (EU) Location:

Remote Fixed Term Contract:

Contract

Who we are: Apsida Life Science has partnered with a leading global clinical research organisation (CRO) that designs and delivers clinical trials with the patient in mind. Our partner defines itself by the difference it makes in patients' lives and the compassion it brings to every aspect of its work.

Key Responsibilities: Lead the development, revision, review, agreement, and maintenance of primary labelling (Company Core Data Sheet (CCDS, European Union Product Information (EUPI), SmPC development and derived documents (labelling text for EU) for assigned compounds. Advise on labelling content, processes, and timelines while ensuring high quality and compliance. Contribute to the global labelling strategies by analysing competitors and their development plans. Drive the continuous improvement of the end-to-end labelling process in a cross-functional environment.

Qualifications: A minimum of a Bachelor’s degree in a scientific discipline is required. Advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred. Ability to lead EU labelling and SmPC development. Minimum 5 years’ experience of centralised labelling requirements. Strong understanding of drug development and worldwide labelling regulations is essential.

What You Get: Total ownership over your country’s clinical sites and regulatory milestones. A long-term 12+ month contract Work life balance Innovation

If you are a seasoned EU Labelling Specialist ready to take the next step in your career, please reach out to Linda Goba at Apsida Life Science.

www.apsida.co.uk +44 (0) 744 134 2145

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process. Website: www.apsida.co.uk