Regulatory Affairs Compliance Associate

1 week ago

Montréal, Canada Novartis Full time

395204BR

**Regulatory Affairs Compliance Associate**:
Canada

**About the role**

Location: Montreal, #LI-Hybrid
13 month contract
About the role:
We are looking for an organized, collaborative and passionate regulatory affairs professional who is driven to help us deliver our innovative treatments to patients. As a compliance lead, you will report directly to the head of regulatory affairs and be responsible for ensuring the department’s compliance to internal and external processes and procedures, and suggesting improvements to processes. You will also be responsible for creating and driving strategic initiatives, and collaborating in a dynamic environment with internal and external stakeholders.
Key Responsibilities:

- Performs periodic audits against department procedures and best practices and prepares reports on findings with recommendations.
- Ensures gap assessments and periodic reviews of SOPs are tracked and completed in a timely manner
- Prepares and maintains various departmental and Health Canada trackers
- Ensures required PSURs are on file and submitted as required.
- Maintains projections for submissions fees; requests opening of Purchase Orders and processes payment of invoices for the department
- Assists the Head of RA with special projects as required.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._

**Role Requirements**

Essential Requirements:

- CEGEP DEC or equivalent
- 3-5 years of work experience

Desirable Requirements:

- Experience in the Pharmaceutical industry
- Bilingual: English and French an asset.

Novartis

**Division**

Development

**Business Unit**

REG AFFAIRS GDD

**Work Location**

Montreal

**Company/Legal Entity**

Novartis Pharma Canada

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes

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