Global CMC Regulatory Lead Submissions & Strategy

Oxford Global Resources; Barcelona; Presencial; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A leading consulting firm is seeking a Global CMC Regulatory Affairs Manager Consultant to support a top pharmaceutical company in Barcelona. This role offers the opportunity to provide regulatory insight, author CMC documents, and coordinate activities for market expansion. The ideal candidate will have at least 5 years of experience in regulatory affairs, a Bachelor's degree in Life Sciences, and fluency in English. This full-time position involves collaboration across multiple teams to ensure compliance with global regulatory requirements.

Formación

• Minimum 5 years in Regulatory CMC field for pharmaceutical products at a global level.
• Good knowledge of international CMC regulatory legislation.
• Demonstrable submission history experience for EU and other international territories.

Responsabilidades

• Provide CMC regulatory insight and advice to multidisciplinary teams.
• Author CMC documents for submission to Health Authorities.
• Coordinate CMC regulatory activities for market expansion.

Conocimientos

Fluency in English for business communication

Strategic regulatory mindset

Strong scientific and technical CMC knowledge

Collaboration with CMOs and Health Authorities

Educación

Bachelor’s degree in Life Sciences or related field

Descripción del empleo

A leading consulting firm is seeking a Global CMC Regulatory Affairs Manager Consultant to support a top pharmaceutical company in Barcelona. This role offers the opportunity to provide regulatory insight, author CMC documents, and coordinate activities for market expansion. The ideal candidate will have at least 5 years of experience in regulatory affairs, a Bachelor's degree in Life Sciences, and fluency in English. This full-time position involves collaboration across multiple teams to ensure compliance with global regulatory requirements.