LATAM Biologics Regulatory Consultant (Senior)

7257 Syneos Health Argentina S.A.; Argentina; A distancia; ARS 1.800.000 - 2.800.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Sr Regulatory Consultant for LATAM with Biologics and CTA experience. The role supports global regulatory CMC for marketed products, preparing submissions and providing cross-functional regulatory guidance across US/Canada/EU.

A Bachelor’s in life sciences and about four years in pharma are preferred, with strong regulatory knowledge and team collaboration. The candidate will work with cross-functional teams and may interact with regulatory agencies to advance product

Formación

• Bachelor’s degree in life sciences with 4 years in pharma or related field.
• Preferred experience supporting Small Molecule programs
• Strong interpersonal and communication skills
• Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines

Responsabilidades

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

Conocimientos

Regulatory knowledge

Cross-functional collaboration

Problem solving

Planning & prioritization

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. The role supports global regulatory CMC for marketed products, preparing submissions and providing cross-functional regulatory guidance across US/Canada/EU.

A Bachelor’s in life sciences and about four years in pharma are preferred, with strong regulatory knowledge and team collaboration. The candidate will work with cross-functional teams and may interact with regulatory agencies to advance product