Regulatory CMC Lead – Cell & Gene Therapy

Syneos Health, Inc; Antioquia; Presencial; COP 150.000.000 - 190.000.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Regulatory CMC Manager for Cell and Gene Therapy to lead global regulatory CMC strategies and submissions. The role collaborates with cross-functional teams to ensure compliance with FDA, EMA, Health Canada and ICH guidelines.

The candidate will contribute to development programs, provide regulatory guidance, and support change controls and GMP investigations to drive successful product development and commercialization.

Formación

• Strong interpersonal skills to exchange complex information and guide others.
• Proficiency in regulatory guidelines from FDA, EMA, Health Canada and ICH.
• Experience in writing and preparing CMC submissions.
• Strategic thinking and strong problem solving abilities.
• Ability to collaborate across cross-functional teams and stakeholders.
• Good planning, prioritization and management of multiple levels.

Responsabilidades

• Reviews CMC sections of regulatory submissions and agency responses.
• Contributes to global regulatory CMC strategies for products.
• Supports development of global CMC strategies and submissions.
• Provides regulatory CMC guidance to cross-functional teams.
• Advises on product compliance topics including change controls and GMP investigations.

Conocimientos

Interpersonal skills

Regulatory guidelines

CMC submissions writing

Strategic thinking

Cross-functional collaboration

Planning and prioritization

cGMP knowledge

Educación

Bachelor's degree in life sciences

Descripción del empleo

Syneos Health is seeking a Regulatory CMC Manager for Cell and Gene Therapy to lead global regulatory CMC strategies and submissions. The role collaborates with cross-functional teams to ensure compliance with FDA, EMA, Health Canada and ICH guidelines.

The candidate will contribute to development programs, provide regulatory guidance, and support change controls and GMP investigations to drive successful product development and commercialization.