Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.


Job Summary

Works closely with the Team Leader to update on all projects related activities in PHRMSCHED and preparation of NOC & TL applications to DCGI Responsible for communicating project related updates to relevant project teams.

Works with internal departments of ARPL-BEC to ensure, compilation and verification of Bio reports in Docubridge before submitting to the internal regulatory affairs group and issues of controlled forms to Clinical operations department. Executes other duties as may be assigned by the management and as training and experience allow.

Job Responsibilities

  • Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Center’s Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures. 
  • Supervises administrative assistance with report compilation and archival of study data post-study.
  • Supervises review of report compilation and archival of study data post-study.
  • Works as a member of a team to achieve all outcomes.
  • Perform all work in support of our corporate values of pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
  • Performs all work in accordance with all established regulatory and compliance and safety requirements and all other duties as assigned
  • Coordinate with Project Coordinator, Team Leader and relevant team members to discuss project updates and ensure project timelines are not compromised.
  • Supervises the coordination with relevant departments/CROs on study reports for compilation and populate into relevant software before submitting to the internal regulatory affairs group for both internal and CRO projects.
  • Provides administrative assistance with report compilation and responsible to coordinate with relevant departments/CROs for all the supporting documents required for the bio report submission (FDA Tables, CS-BE, Investigator documents etc.).
  • Responsible for issue of controlled forms to operations controlled by BEC-Projects.
  • Executes other duties as may be assigned by the management and as training and experience allow.
  • Participates in the creation, development and revision of ARPL – BEC SOP’s.
  • Preparation NOC and TL applications to DCGI for permission to conduct bioequivalence/bioavailability studies
  • Responsible for updating the projects status in the relevant database

Job Requirements

Science Graduate

Previous experience in data management

Proficient in the use of Microsoft Office software



At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.


from Apotex – Scientific & Regulatory Affairs http://bit.ly/2Jficnx

About Apotex

Apotex Inc. was founded in 1974, and is the largest Canadian-owned pharmaceutical company. From its 2 employees, 5,000 square foot beginning, the company has grown to employ over 6,500 people in research, development, manufacturing and distribution facilities world-wide. The Canadian operations of the Apotex Group of Companies with 5,800 employees now occupy over 3 million square feet in Montreal, Richmond Hill, Toronto, Etobicoke, Mississauga, Brantford, Windsor, Winnipeg, London, Calgary and Vancouver. Apotex produces more than 300 generic pharmaceuticals in approximately 4,000 dosages and formats which, in Canada, are used to fill over 89 million prescriptions a year – the largest amount of any pharmaceutical company in this country.

Today, Apotex is a necessary and trusted member of Canada’s healthcare community. The company’s pharmaceuticals can be found in virtually every pharmacy and healthcare facility in Canada and are exported to over 115 countries around the globe. Export markets represent an ever growing portion of the total sales. Apotex has also established a presence through subsidiaries, joint ventures or licensing agreements in Australia, Belgium, Czech Republic, Mexico, Netherlands, New Zealand, Poland, Turkey, and the in, to name just a few. Healthcare professionals around the world rely on Apotex for quality and value.

Although the company’s own business is developing and manufacturing generic pharmaceuticals, the success of Apotex has enabled it to diversify into a number of other health-related areas. The Apotex Pharmaceutical Group of Companies also researches, develops, manufactures and distributes fine chemicals, non-prescription and private label medicines, and disposable plastics for medical use.

The worldwide sales of the Apotex Group of companies exceed $1 billion (Canadian $) per year.