Senior CMC Regulatory Affairs Leader (Phase III/MAA)

Decskill; Portugal; Presencial; EUR 55 000 - 90 000; Tempo integral

Resumo da oferta

A leading IT consulting firm is looking for a professional with expertise in CMC regulatory affairs to draft and manage regulatory dossiers for submissions. Key skills include strong writing, leadership, and knowledge of EMA/FDA regulations. Fluency in professional English is essential. The position emphasizes collaboration in a cross-functional setting. Interested candidates should send their CV to the provided email.

Qualificações

• Draft and lead CMC regulatory dossiers for Phase III and MAA submissions.
• Strong knowledge of EMA / FDA / ICH regulatory requirements.
• Experience managing CROs in a matrix and cross‑functional environment.

Conhecimentos

CMC expertise

Strong writing skills

Leadership

Verbal communication

Fluent professional English

Descrição da oferta de emprego

A leading IT consulting firm is looking for a professional with expertise in CMC regulatory affairs to draft and manage regulatory dossiers for submissions. Key skills include strong writing, leadership, and knowledge of EMA/FDA regulations. Fluency in professional English is essential. The position emphasizes collaboration in a cross-functional setting. Interested candidates should send their CV to the provided email.