Regulatory Strategist, LATAM - Biologics & CMC

Syneos Health, Inc.; Argentina; Presencial; ARS 106.678.000 - 167.637.000; Jornada completa

Descripción de la vacante

Syneos Health, Inc. is seeking a Sr Regulatory Consultant for LATAM with biologics and CTA experience. You will support global regulatory CMC, prepare submissions, and collaborate with cross-functional teams to drive product development and lifecycle management.

The role emphasizes regulatory strategy and interaction with agencies across US, Canada, and EU, with a focus on LATAM regulatory requirements and timelines.

Formación

• Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or related life-science field.
• Typically requires 4 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience.
• Preferred experience supporting Small Molecule programs.

Responsabilidades

• Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU.
• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
• Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects

Conocimientos

Regulatory strategy

CMC submissions

Cross-functional collaboration

FDA/EMA knowledge

Educación

Bachelor's degree in Life Sciences

Descripción del empleo

Syneos Health, Inc. is seeking a Sr Regulatory Consultant for LATAM with biologics and CTA experience. You will support global regulatory CMC, prepare submissions, and collaborate with cross-functional teams to drive product development and lifecycle management.

The role emphasizes regulatory strategy and interaction with agencies across US, Canada, and EU, with a focus on LATAM regulatory requirements and timelines.