Regulatory Affairs Associate

GSK - Mississauga, ON (30+ days ago)

Apply Now

Site Name: Canada - Ontario - Mississauga
Posted Date: Jun 25 2020

  • Please note - this is a 12 month contract opportunity *
GlaxoSmithKline, one of the world’s leading research-based pharmaceutical and health-care companies, is committed to improving the quality of life by enabling people to do more, feel better, and live longer. GSK’s Regulatory Affairs department is a world-class team of professionals who are dedicated to excellence in all aspects of regulatory affairs. We are actively looking for a motivated, bold, decisive, and innovative team player to join and add value to our dynamic team. If you are an energetic, career-minded professional with a passion for leadership, a focus on solutions, and a commitment to outstanding performance, we invite you to apply to our exciting and rewarding role. We welcome applicants with previous experience working in Regulatory Affairs who are looking to gain valuable experience working with one of Canada’s best employers.

Primary Responsibilities:
Provides input into the planning of submissions/activities
Assists in the preparation of regulatory submissions/activities (i.e., NDSs, SNDSs, CTAs, NCs, Training, Compliance, etc) to aggressive targets, within a team environment
Ensures regulatory compliance with Health Canada, industry, and GSK codes and guidelines in alignment with business needs
Assists in the preparation of internal reports or responses to Health Canada requests
Establishes contact and communicates with global and local teams on project related plans and issues
Identifies and responds to issues related to assigned projects, resolves basic regulatory questions
Communicates with and may build relationship with Health Canada
Interprets Canadian regulations, guidelines and policies as they apply to GSK regulatory activities

Qualifications Required:
B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
Some experience in regulatory affairs
Must possess an understanding of the Canadian Food and Drug Regulations, relevant guidelines and policies
Must have knowledge of regulatory requirements and processes for all types of submissions
Must have a basic understanding of drug development and commercialization process
Agile with the ability to react quickly, provide creative solutions to problems, and navigate change
Good oral and written communication skills
Some demonstrated negotiation skills
Accountable to simultaneously work on multiple projects and to meet tight timelines
Excellent attention to detail and accuracy of work
Act with integrity and demonstrate 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
Competence with electronic business environment and computer skills including Word, Excel, PowerPoint, Outlook

Preferred Qualifications:
Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs

  • LI-GSK
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome 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.

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.