Senior Regulatory CMC Consultant — Small Molecule Expert

Syneos Health; Municipio de Esquel; Presencial; ARS 88.483.829 - 147.473.049; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Mgr/Sr Regulatory CMC Consultant focused on small molecule products with Veeva RIM expertise. You will support global regulatory CMC strategies, review submissions, and guide cross‑functional teams in development and commercialization programs.

Ideal candidates bring strong regulatory guidelines knowledge, extensive experience in CMC submissions, and strategic thinking to enable global expansion across markets.

Formación

• Excellent interpersonal skills to exchange complex information with others and guide others.
• Proficiency in regulatory guidelines (FDA, EMA, Health Canada, LATAM, Middle East, and 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.
• Capable of strategic thinking with ability to resolve complex and ambiguous situations.
• Sound knowledge of cGMP, FDA, EMA, ICH.

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 knowledge

CMC submissions

Strategic thinking

Problem solving

Cross-functional collaboration

Communication skills

Planning & prioritization

cGMP knowledge

FDA/EMA/ICH familiarity

Educación

Bachelor's degree in life sciences

Herramientas

Veeva RIM

Descripción del empleo

Syneos Health is seeking a Mgr/Sr Regulatory CMC Consultant focused on small molecule products with Veeva RIM expertise. You will support global regulatory CMC strategies, review submissions, and guide cross‑functional teams in development and commercialization programs.

Ideal candidates bring strong regulatory guidelines knowledge, extensive experience in CMC submissions, and strategic thinking to enable global expansion across markets.