Senior Regulatory Consultant, EU CMC & Lifecycle

Syneos Health; Elsene; Sur place; EUR 24 000 - 42 000; Plein temps

Résumé du poste

Syneos Health is seeking a Sr Regulatory Consultant (CMC, EU mkt) for an office-based role in India. The incumbent will lead regulatory submissions, including Module 3 CMC sections, for INDs and post-approval variations, with strong EU market experience, up to 25% travel, and potential line management of a small team depending on location.

The role requires 6–9 years in Regulatory Affairs, preferably in biologics, and solid experience with EU and ROW submissions, drug substance and product

Qualifications

• BS degree in science or related field; PhD preferred.
• Experience in regulatory submissions (IND, NDA, MAA, CTD) including electronic submissions.
• Fluent in English (written and spoken).

Responsabilités

• Lead day-to-day contribution to regulatory projects and teams.
• Authors and reviews Module 3 CMC sections for submissions.
• Prepare regulatory submissions for INDs, product registrations, and post‑approval activities.

Connaissances

English fluency

Communication skills

Analytical skills

Problem solving

Independent work

Team collaboration

Formation

Bachelor’s degree in science

PhD preferred

Outils

Microsoft Office

Description du poste

Syneos Health is seeking a Sr Regulatory Consultant (CMC, EU mkt) for an office-based role in India. The incumbent will lead regulatory submissions, including Module 3 CMC sections, for INDs and post-approval variations, with strong EU market experience, up to 25% travel, and potential line management of a small team depending on location.

The role requires 6–9 years in Regulatory Affairs, preferably in biologics, and solid experience with EU and ROW submissions, drug substance and product