Senior Regulatory CMC Lead — Small Molecule

7250 inVentiv Health Clinical Mexico, S.A. de C.V.; Argentina; A distancia; ARS 1.000.000 - 1.800.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Mgr/Sr Regulatory CMC Consultant for small molecule projects and Veeva RIM expertise. The role supports global CMC strategies, prepares submissions, and provides regulatory guidance to cross-functional teams across development and commercialization programs.

Successful candidates will have strong knowledge of FDA/EMA/ICH guidelines, cGMP, and a biology- or chemistry-based background.

Formación

• Experience preparing and guiding CMC submissions for regulators (FDA, EMA, etc.).
• Ability to interpret global regulatory requirements and advise cross-functional teams.
• Strong problem solving, planning, and communication skills.

Responsabilidades

• Reviews CMC sections of regulatory submissions and interfaces with agencies.
• Contributes to global CMC strategies for development and commercial products.
• Guides cross-functional teams on regulatory CMC topics and changes.
• Advises on product compliance topics including deviations and GMP investigations.

Conocimientos

Regulatory CMC knowledge

Cross-functional collaboration

Strategic thinking

Regulatory guidelines experience

Educación

Bachelor's degree in Life Sciences/Regulatory Affairs

Herramientas

Veeva RIM

Descripción del empleo

Syneos Health is seeking a Mgr/Sr Regulatory CMC Consultant for small molecule projects and Veeva RIM expertise. The role supports global CMC strategies, prepares submissions, and provides regulatory guidance to cross-functional teams across development and commercialization programs.

Successful candidates will have strong knowledge of FDA/EMA/ICH guidelines, cGMP, and a biology- or chemistry-based background.