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Regulatory Affairs Specialist
2 weeks ago
**Summary**:
Location: Montreal, #LI-Hybrid About the role: The role reports to Regulatory Affairs Franchise Lead and will work with different team members. Temporary - 9 to 12 months
**About the Role**:
**Key Responsibilities**:
- Assists in the preparation of and/or review of various regulatory submissions for new or marketed products and ensures optimal approval conditions and labelling.
- Prepares Clinical Trial Applications and ensure timely submission to, and authorization from Health Canada.
- Assists in the preparation of Canadian development/registration strategies in conjunction with other cross-functional team members.
- Ensures that submissions are accurate, complete and compliant with regulatory requirements.
- Maintains high quality and professional interactions with Health Canada.
- Evaluates proposed changes to marketed products for regulatory impact and liaises with internal stakeholders to assemble necessary documentation.
- Completes other Regulatory Affairs duties as required to ensure compliance with Canadian requirements.
**Essential Requirements**:
- At least 1 years of Regulatory Affairs experience in the Pharmaceutical Industry.
- Bachelor’s degree in science or in a related discipline.
- Good knowledge of Health Canada regulations, policies and guidelines related to drug submissions.
- Fluency in English as a business language; bilingualism (English and French) is a strong asset.
- Good interpersonal, communication and time management skills.
Division
Development
Business Unit
Innovative Medicines
Location
Canada
Site
Montreal
Company / Legal Entity
CA04 (FCRS = CA004) NOVARTIS PHARMA CANADA INC.
Functional Area
Research & Development
Job Type
Full time
Employment Type
CDD (Durée déterminée)
Shift Work
No
