Sr Regulatory CMC Lead - Small Molecule & Veeva RIM

Syneos Health; Argentina; Presencial; ARS 1.800.000 - 3.400.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking aMgr/Sr Regulatory CMC Consultant for Small Molecule experience, with Veeva RIM expertise, to lead global regulatory CMC activities. This role supports development teams, prepares regulatory submissions, and drives strategic CMC plans across markets.

The candidate should have strong knowledge of FDA, EMA, ICH guidelines and proven ability to collaborate across functions while delivering timely, compliant outcomes.

Formación

• Strong interpersonal skills to exchange complex information and guide others.
• Proficiency in regulatory guidelines (FDA, EMA, Health Canada, LATAM, Middle East, ICH).
• Experience in the preparation, including writing, of CMC submissions.
• Strategic thinking and strong problem-solving skills.
• Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner.
• Strong sense of planning and prioritization, and the ability to work with all levels of management.
• Sound knowledge of cGMP, FDA, EMA, ICH.
• Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field.

Responsabilidades

• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
• Contributes to the development of global regulatory CMC strategies for commercial products.
• Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions.
• Provides regulatory CMC guidance to cross-functional teams and key stakeholders.
• Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.

Conocimientos

Regulatory CMC knowledge

CMC submissions

Cross-functional collaboration

Strategic thinking

Communication

Planning & prioritization

Educación

Bachelor's degree in Life sciences

Descripción del empleo

Syneos Health is seeking aMgr/Sr Regulatory CMC Consultant for Small Molecule experience, with Veeva RIM expertise, to lead global regulatory CMC activities. This role supports development teams, prepares regulatory submissions, and drives strategic CMC plans across markets.

The candidate should have strong knowledge of FDA, EMA, ICH guidelines and proven ability to collaborate across functions while delivering timely, compliant outcomes.