Senior Regulatory CMC Consultant - Small Molecule | Remote

Syneos Health, Inc.; España; A distancia; EUR 104.000 - 156.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Veeva RIM experience

Descripción de la vacante

Syneos Health is seeking a Mgr/Sr Regulatory CMC Consultant specializing in Small Molecule and Veeva RIM. This remote role supports global regulatory CMC strategies and submissions across multiple markets.

The candidate will guide cross-functional teams, ensure compliance with FDA/EMA/Health Canada guidelines, and contribute to change controls and GMP investigations. Ideal for a senior professional with strong regulatory experience, excellent communication, and a strategic mindset to accelerate

Formación

• Experience in regulatory CMC submissions.
• Proficiency with FDA, EMA and Health Canada guidelines.
• Strong communication and cross-functional collaboration skills.

Responsabilidades

• Reviews CMC sections of regulatory submissions and interactions with agencies.
• Contributes to the development of global regulatory CMC strategies.
• Provides regulatory CMC guidance to cross-functional teams.
• Supports regulatory assessment on changes, deviations and GMP investigations.

Conocimientos

Regulatory knowledge

Educación

Bachelor's degree in life sciences

Herramientas

Veeva RIM

Descripción del empleo

Syneos Health is seeking a Mgr/Sr Regulatory CMC Consultant specializing in Small Molecule and Veeva RIM. This remote role supports global regulatory CMC strategies and submissions across multiple markets.

The candidate will guide cross-functional teams, ensure compliance with FDA/EMA/Health Canada guidelines, and contribute to change controls and GMP investigations. Ideal for a senior professional with strong regulatory experience, excellent communication, and a strategic mindset to accelerate