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.
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 [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
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