Primary Responsibilities: 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 or the preparation of CTAs. In this position you may participate in: 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. Qualifications Required 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? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. We are 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 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. Find out more on our career site.