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 hocrequests 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.
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