Lead Regulatory CMC Consultant: Small Molecule RIM Remote

Syneos Health, Inc.; Argentina; Remote; ARS 136.577.000 - 197.278.000; Vollzeit

Zusammenfassung

Syneos Health is seeking a Mgr/Sr Regulatory CMC Consultant for small molecule work with Veeva RIM experience. This remote role supports global regulatory CMC strategies across development and marketed products, collaborating with cross-functional teams to ensure compliance.

The ideal candidate has strong regulatory knowledge (FDA/EMA/ICH), hands-on experience writing CMC submissions, and a strategic mindset to guide change controls and GMP investigations while maintaining efficient timelines.

Qualifikationen

• Strong experience writing CMC submissions.
• Knowledge of FDA/EMA/ICH guidelines and global regulatory standards.
• Experience developing global regulatory CMC strategies for small molecules.
• Bachelor’s degree in biology/chemistry or regulatory affairs.
• Excellent cross-functional communication and planning.

Aufgaben

• Review CMC sections of regulatory submissions and responses.
• Contribute to global regulatory CMC strategy development for products.
• Collaborate with development teams on CMC considerations and submissions.
• Provide regulatory guidance on change controls, deviations, and GMP topics.
• Support cross-functional teams to ensure regulatory compliance.

Kenntnisse

Interpersonal skills

Regulatory knowledge

CMC submissions

Strategic thinking

Collaboration

Ausbildung

Bachelor's degree in Life Sciences

Tools

Veeva RIM

Jobbeschreibung

Syneos Health is seeking a Mgr/Sr Regulatory CMC Consultant for small molecule work with Veeva RIM experience. This remote role supports global regulatory CMC strategies across development and marketed products, collaborating with cross-functional teams to ensure compliance.

The ideal candidate has strong regulatory knowledge (FDA/EMA/ICH), hands-on experience writing CMC submissions, and a strategic mindset to guide change controls and GMP investigations while maintaining efficient timelines.