[Hiring] Local Regulatory @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
• PQRs
• Annual Drug Notifications
• Coordinating Clarifax responses

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

CMC Biologic Authoring experience an advantage.

Qualifications

• Experience with LCM submissions
• Direct interaction with Health Canada
• Ability to provide local Canada regulatory intelligence
• CMC Biologic Authoring experience (advantage)

Requirements

• Support client submissions to Health Canada
• Work self-sufficiently in supporting life cycle submissions in Canada

Benefits

• Passionate about developing our people through career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Commitment to building an inclusive culture
• Opportunity to shape solutions that impact lives