Regulatory Affairs Specialist – Early Clinical (ADC) Remote

Byondis; Nijmegen; Híbrido; EUR 85 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

30 days annual leave

Pension scheme

Option to partly work remotely

Competitive salary

Resumo da oferta

Byondis, a Nijmegen-based biopharmaceutical company, seeks a Regulatory Affairs Specialist to drive regulatory strategy and manage submissions for early development and clinical programs.

You will coordinate CTAs across regions, contribute to CMC and nonclinical dossiers, and advise teams on regulatory requirements, while collaborating with scientists, manufacturing, and external partners.

Qualificações

• A Master’s or preferably PhD degree in life sciences, chemistry or a related discipline.
• At least five years of relevant experience in Regulatory Affairs, preferably in early clinical development.
• Experience with ADCs; small-molecule with exposure to biologics is acceptable.

Responsabilidades

• Interpret regulatory requirements and prepare submission documentation.
• Coordinate CTAs across regions and ensure timely availability of documents.
• Write CMC and nonclinical sections of clinical trial dossiers.
• Advise project teams on applying regulatory requirements and communicate with authorities.

Conhecimentos

Regulatory strategy

Regulatory submissions

CTA submissions

CMC writing

Nonclinical writing

Project coordination

Formação académica

PhD in life sciences

Master's in life sciences

Ferramentas

Microsoft Office

CTIS training

Descrição da oferta de emprego

Byondis, a Nijmegen-based biopharmaceutical company, seeks a Regulatory Affairs Specialist to drive regulatory strategy and manage submissions for early development and clinical programs.

You will coordinate CTAs across regions, contribute to CMC and nonclinical dossiers, and advise teams on regulatory requirements, while collaborating with scientists, manufacturing, and external partners.