Remote CMC Regulatory Consultant (Biologics) Canada

Syneos Health India Private Limited; United States; À distance; USD 64 000 - 93 000; Plein temps

Résumé du poste

Syneos Health, a leading life sciences services organization, seeks a CMC Regulatory Consultant (Biologics Must Have) with Canada remote availability. You will support Health Canada submissions for biologics and rare disease portfolios, collaborating with cross-functional teams to ensure compliant lifecycle documentation.

Candidate must have direct Health Canada submission experience, be adept in coordinating responses, and provide regulatory intelligence for ongoing Canada regulatory

Qualifications

• Experience with Health Canada biologics regulatory submissions is required.
• Experience preparing Level III submissions, sNDS, PQRs and annual drug notifications is essential.
• Ability to coordinate ClaRifax responses and interact with Health Canada is required.

Responsabilités

• Support client submissions to Health Canada for a biologic/small molecule rare disease product portfolio.
• Prepare and update regulatory documentation and local Module 3 documents.
• Coordinate responses to Health Canada and provide regulatory intelligence for lifecycle submissions in Canada.

Connaissances

Health Canada submissions

CMC/Regulatory writing

Regulatory intelligence

Description du poste

Syneos Health, a leading life sciences services organization, seeks a CMC Regulatory Consultant (Biologics Must Have) with Canada remote availability. You will support Health Canada submissions for biologics and rare disease portfolios, collaborating with cross-functional teams to ensure compliant lifecycle documentation.

Candidate must have direct Health Canada submission experience, be adept in coordinating responses, and provide regulatory intelligence for ongoing Canada regulatory