[Hiring] CMC Regulatory Consultant @Syneos Health

Role Description

Candidate will be responsible for supporting client submissions to Health Canada for a Biologic / Small molecule rare disease product portfolio.

Experience of LCM submissions essential including:

• Level III Submissions
• sNDS Submissions, including updating local Module 3 documents
• PQRs
• Annual Drug Notifications
• Coordinating Clarifax responses

Experience of direct interaction with Health Canada is essential. CMC Authoring experience essential. Candidate must be able to provide local Canada regulatory intelligence and work self-sufficiently in supporting life cycle submissions in Canada.

Qualifications

• Experience with LCM submissions
• Direct interaction with Health Canada
• CMC Authoring experience
• Ability to provide local Canada regulatory intelligence
• Ability to work self-sufficiently

Requirements

• Experience in supporting client submissions to Health Canada
• Knowledge of Biologic / Small molecule rare disease product portfolio

Benefits

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture