# Regulatory Affairs Specialist

**Company**: GSK
**Location**: Mississauga
**Work arrangement**: hybrid
**Job type**: full-time
**Salary**: CAD 82,000 to CAD 132,000
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Mississauga-Milverton-Drive/Regulatory-Affairs-Associate--Contract-_450843-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_ba5b9bcf-9a8

## Description

We are seeking a Regulatory Affairs Specialist to join our team in Mississauga, Ontario. As a Regulatory Affairs Specialist, you will provide input into the planning of submissions/activities, assist in the preparation of regulatory submissions/activities, ensure regulatory compliance with Health Canada, industry, and GSK codes and guidelines, and interpret Canadian regulations, guidelines, and policies.

**Responsibilities:**

- Provide input into the planning of submissions/activities

- Assist in the preparation of regulatory submissions/activities (e.g., NDSs, SNDSs, CTAs, NCs, Training, Compliance)

- Ensure regulatory compliance with Health Canada, industry, and GSK codes and guidelines

- Assist in the preparation of internal reports or responses to Health Canada requests

- Establish contact and communicate with global and local teams on project-related plans and issues

- Identify and respond to issues related to assigned projects, resolve basic regulatory questions

- Communicate with and may build relationships with Health Canada

- Interpret Canadian regulations, guidelines, and policies as they apply to GSK regulatory activities

- Experience working with Veeva Vault

**Requirements:**

- B.Sc. in life science or relevant scientific field (e.g., pharmacology, toxicology, chemistry)

- Some experience in regulatory affairs

- Understanding of the Canadian Food and Drug Regulations, relevant guidelines, and policies

- Knowledge of regulatory requirements and processes for all types of submissions

- Basic understanding of drug development and commercialization process

- Agile with the ability to react quickly, provide creative solutions to problems, and navigate change

- Good oral and written communication skills

- Demonstrated negotiation skills

- Accountable to simultaneously work on multiple projects and meet tight timelines

- Excellent attention to detail and accuracy of work

- Acts with integrity and demonstrates a strong quality mindset

- Ability to provide and receive feedback, raise issues, share experiences, and lessons learned

- Proactive and seeks to constantly learn and develop

- Collaborative with the ability to work with diverse groups of individuals in a team

- Competence with electronic business environment and computer skills including Word, Excel, PowerPoint, Outlook

**Preferred Qualifications:**

- Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs

**What We Offer:**

- Annual compensation: CAD 82,000 to CAD 132,000, determined based on experience, qualifications, and internal equity

- Hybrid work model combining on-site collaboration with flexible remote work

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## Skills

### Required
- regulatory affairs
- life science
- pharmacology
- toxicology
- chemistry
- Canadian Food and Drug Regulations
- Veeva Vault
- Word
- Excel
- PowerPoint
- Outlook

### Nice to have
- graduate degree in Regulatory Affairs
- Post-Graduate Certificate in Regulatory Affairs

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Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Mississauga-Milverton-Drive/Regulatory-Affairs-Associate--Contract-_450843-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)