(6 Month Contract Position)

Job Purpose:

The mandate of the Submission Associate (SA) role is to support various regulatory submission related activities and other projects within the Regulatory Department. The role will require the incumbent to contribute to Health Canada submissions, timely feedback & updates and operational excellence activities. The role may require specialization in one particular area, such as CMC.

Your Responsibilities:

Submission

• Assist Therapy Area staff in the planning and preparation of regulatory submissions (CTA, NDS, S/NDS, N/C)
• Participate in submission preparation teams

Analysis

• Assist in the regulatory and corporate compliance activities for GSK products

Liaise with diverse local and global groups

• Regulatory Affairs, Clinical Studies, Medical Information, Drug Safety & Compliance

Ad hoc requests

• Participate in ad hoc requests to support departmental activities.

Why you?

Basic Qualifications:

• University Degree Health Sciences e.g., Biology, Chemistry, Pharmacology, Toxicology
• Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook
• Theoretical understanding of Regulatory Affairs and the Drug Development process is required
• Results oriented with a proven ability to prioritize work and meet challenging deadlines
• Well developed time-management and multi-tasking ability
• Good communication skills including listening, summarizing, probing, clarifying
• Adaptive communication style with ability to influence and build relationships with others across Divisions
• Proven ability to interact effectively with a diverse group of business partners individually and within a team environment
• Diligent with excellent attention to detail and accuracy of work
• Acts with integrity and demonstrates a strong quality mindset
• Takes initiative and follows through
• Very good thinking, creative problem solving skills and sound judgment
• Quick learner with ability to work in a fast paced and changing environment
• Demonstrated ability to remain calm under pressure
• Ability to provide and receive feedback, raise issues, share experiences and lessons learned

Preferred Qualifications:

• Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs
• Previous pharmaceutical industry experience

Why GSK?

We’re uniting science, technology and talent to make a difference in more people’s lives, and revolutionising the way we do R&D.

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

No single scientist, nor any one technology can keep us all ahead of disease. That’s why we build important collaborations with commercial and academic partners to advance our understanding of disease and what it takes to get ahead. In the past three years, we’ve doubled the number of partnerships we’ve signed, because of our belief in their significant impact on our process.

Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including infectious diseases, HIV, oncology and immunology as well at pursuing other science-led opportunities outside our core areas. Many have the potential to be first or best-in-class opportunities for patients and since 2017, we’ve delivered 13 major approvals and more than doubled the number of potential new vaccines and medicines in Phase 3 and registration to 23.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do the most good. If a project doesn’t pan out, we take what we’ve learned and apply it elsewhere.

#LI-GSK

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

As a health and science-based organization, GSK is committed to following the recommendations as set out by Health Canada and taking all necessary steps to help curb the spread of COVID-19 which includes getting the COVID-19 vaccine. We feel strongly that this is the best way to help protect those we value most: our employees, families, communities and the patients and consumers we serve. To that end, we are taking an important step to ensure the safety of our employees during this global public health crisis.

Only employees who are fully vaccinated against COVID-19 may attend our Mississauga and Laval corporate offices. In addition, all customer-facing employees who, as part of their job, attend healthcare settings such as hospitals, pharmacies, doctors’ offices and dentists’ offices will need to be fully vaccinated against COVID-19. Notwithstanding the foregoing, employees may seek an accommodation for human rights-related reasons, including medical or disability-related conditions, or religious beliefs.

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