Remote LATAM Regulatory Lead, Biologics & CMC

Syneos Health, Inc.; Estado de México; Híbrido; MXN 900.000 - 1.200.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Sr Regulatory Consultant for LATAM with Biologics and CTA experience, remote in Mexico. You will support global regulatory CMC for marketed products, contribute to submissions, and provide regulatory expertise to cross-functional teams across drug development and commercialization.

The role requires strong knowledge of FDA/EMA/Health Canada guidelines, cGMP, and demonstrated ability to collaborate and communicate effectively in a fast-paced environment to deliver

Formación

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

Responsabilidades

• Execute regulatory CMC strategy and submissions with focus on US/CA/EU
• Review CMC sections of regulatory submissions and interact with agencies
• Collaborate on global regulatory CMC strategies and submissions
• Serve as primary regulatory CMC contact for assigned products/projects

Conocimientos

Regulatory guidelines

Cross-functional collaboration

Planning & prioritization

Communication

cGMP knowledge

Educación

Bachelor's degree in life sciences

Descripción del empleo

Syneos Health is seeking a Sr Regulatory Consultant for LATAM with Biologics and CTA experience, remote in Mexico. You will support global regulatory CMC for marketed products, contribute to submissions, and provide regulatory expertise to cross-functional teams across drug development and commercialization.

The role requires strong knowledge of FDA/EMA/Health Canada guidelines, cGMP, and demonstrated ability to collaborate and communicate effectively in a fast-paced environment to deliver