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Regulatory Affairs Associate/project Leader

1 month ago

Mississauga, Canada GSK Full time

**Site Name**: Mississauga Milverton Drive
**Posted Date**: Sep 19 2024

Are you ready to take on a pivotal role that shapes the future of healthcare in Canada? At GSK, we are on a mission to deliver innovative solutions that enhance patient care and improve health outcomes. In this role, you’ll collaborate with diverse local and global teams, bridging the gap between compliance and business needs. Your expertise will ensure that our Canadian regulatory requirements are not just met but exceeded, empowering us to make a lasting impact in the healthcare landscape. If you thrive in a fast-paced environment and are passionate about regulatory affairs, we want you to help us lead the charge towards a healthier tomorrow
- **There are two positions open**
- Posting expires on October 2, 2024 at 23:59 EST

**Key Accountabilities/Responsibilities**:

- Provides input into and/or develops plans for submissions/activities.
- Supports and/or leads the preparation of regulatory submissions (i.e., NDSs, SNDSs, CTAs) to aggressive targets, within a team environment.
- Ensures regulatory compliance with Health Canada, industry, and GSK codes and guidelines in alignment with business needs.
- Communicates with multiple local and global cross-functional groups to ensure Canadian regulatory needs are met.
- Collaborates with internal partners to achieve rapid approval of submissions with optimal labelling, and/or achieve timely completion of projects.
- Assists in the preparation of and/or prepares responses to Health Canada requests.
- Identifies and responds to issues related to assigned projects.

**Basic Qualifications**:

- B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
- 1-3 years of experience in Canadian regulatory affairs
- Good working knowledge of the Canadian Food and Drug Regulations, relevant guidelines and policies
- Good understanding of drug development and commercialization process
- Agile with the ability to react quickly, provide creative solutions to problems, and navigate change.
- Able to contribute to the development of regulatory strategies aligned with commercial objectives.
- Excellent oral and written communication with the ability to present to small and large groups.
- Good negotiation skills
- Accountable to simultaneously manage 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. Ensures that skills meet changing business needs.
- Collaborative with the ability to work with diverse groups of individuals in a team and to express opinions, including as part of group discussions. Open to diverse ideas, styles, and perspectives
- Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook, Veeva Vault

**Preferred Qualifications**
- Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs
- Canadian CMC Regulatory experience with small molecules, vaccines, and other biologics is an asset.

LI-HYBRID

LI-GSK

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

**Important notice to Employment businesses/ Agencies