Regulatory Affairs Specialist

3 days ago

Montréal, Canada Novartis Full time

**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

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