Specialist, Regulatory Affairs

Toronto, ON, CA, Canada

Job Description

Location:



243 Consumers Road, Toronto, Ontario, M2J 4W8
At Shoppers Drug Mart, we're innovating health and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we're caring and supporting our customers in new ways every day.

With more than 1,300 locally owned and operated stores from coast to coast, the Shoppers Drug Mart network is more than a great place to shop, it's a great place to work. We're committed to building our talented team who champion collaboration, kindness and inclusivity. Join our team, and help recognize a healthy future for your career and for all Canadians.

Why this role is important?



Summary




The Sanis Health Inc. Regulatory Affairs Specialist (20-month Maternity Leave Coverage) will work in collaboration with the Regulatory Affairs Manager and the appropriate stakeholders to assemble high quality regulatory submissions. They will also help ensure company compliance with internal and government requirements.

Essential

D

uties and Responsibilities



Compile Abbreviated New Drug Submissions (ANDS), Supplemental New Drug Submissions (SANDS), Labelling Only Submissions and Level IIIs. Coordinate with external partners for eCTD submission to Health Canada. Compile and send provincial formulary submissions. Facilitate the preparation and submission of responses to questions and/or concerns from regulatory agencies within the timeframes specified. Labelling mock-up, review, coordination and maintenance of label documentation. Update internal product documentation and tracking logs. Maintain up-to-date knowledge of provincial and federal regulations and guidelines. May serve on multidisciplinary project teams to help with company initiatives as needed.

Supervisio

n/

Leaders

h

ip



This position does not have any direct reports.

Education



Requires a university degree in sciences; pharmacy, chemistry, microbiology, biology or similar, recognized as equivalent to Canadian science degree.

Experience



1 or more years of previous experience working with Canadian drug submissions Understanding and working knowledge of the Food and Drugs Act Excellent organizational skills Strong attention to detail Critical thinking skills Ability to work under minimal supervision Ability to work with strict timelines and handle multiple priorities Excellent oral and written communication skills Ability to build relationships and work collaboratively in a team environment Advanced user of Microsoft Office and Adobe Acrobat Flexibility and ability to embrace changes, whether reflective of new responsibilities or changing business needs

Why work at Shoppers Drug Mart?




Acting as consultants, supporting internal customers and the Associate-Owners, you will get experience unique to the retail industry while working for an award-winning national brand. Benefit from a purchase discount program, competitive pay and online learning through Academy.


Take ownership of your work and find more ways to care about your work, co-workers, customers and community.

How You'll Succeed:




At Shoppers Drug Mart Inc., we seek great people to continually strengthen our culture. We believe great people model our values, are authentic, build trust and make connections.


If that sounds like you, and you are open-minded, responsive to change and up to the challenges provided in a fast-paced retail environment, apply today.

Employment Type:




Full time

Type of Role:




Temporary with Benefits (Fixed Term)
Shoppers Drug Mart Inc. recognizes Canada's diversity as a source of national pride and strength. We have made it a priority to reflect our nation's evolving diversity in the products we sell, the people we hire, and the culture we create in our organization. Accommodation is available upon request for applicants with disabilities in the recruitment and assessment process and when hired.


In addition, we believe that compliance with laws is about doing the right thing. Upholding the law is part of our Code of Conduct - it reinforces what our customers and stakeholders expect of us.

Please Note: If you have Employee Self Service (ESS) on Workday, apply to this job via the Workday application.




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#SS #LEGAL #ON

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Job Detail

  • Job Id
    JD2419696
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Contract
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Toronto, ON, CA, Canada
  • Education
    Not mentioned