Remote LATAM Biologics Regulatory Consultant

Syneos Health, Inc.; España; A distancia; EUR 105.000 - 158.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Sr Regulatory Consultant - LATAM with Biologics & CTA experience to lead regulatory CMC activities for LATAM, US, and EU markets. This remote role supports cross-functional teams and regulatory submissions across multiple product types.

The position requires strong knowledge of FDA/EMA guidelines, cGMP, and LATAM regulatory processes, and offers an opportunity to impact global development timelines while working with a diverse, global team.

Formación

• Bachelor's degree in life sciences or related field.
• Typically 4+ years of regulatory experience in pharma/biologics.
• Experience with LATAM regulatory submissions preferred.

Responsabilidades

• Execute regulatory CMC lifecycle management for LATAM/US/EU markets.
• Review CMC sections and regulatory interactions with agencies.
• Collaborate with cross-functional teams to develop global regulatory strategies.

Conocimientos

Regulatory Affairs

CMC submissions

FDA/EMA knowledge

Biologics

Educación

Bachelor's degree in life sciences

Descripción del empleo

Syneos Health is seeking a Sr Regulatory Consultant - LATAM with Biologics & CTA experience to lead regulatory CMC activities for LATAM, US, and EU markets. This remote role supports cross-functional teams and regulatory submissions across multiple product types.

The position requires strong knowledge of FDA/EMA guidelines, cGMP, and LATAM regulatory processes, and offers an opportunity to impact global development timelines while working with a diverse, global team.