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

Responsible for compilation and submission of dossiers for registration of Apotex products in identified markets. Also responsible for providing support and regulatory guidance to a team of RA Associates in the completion of projects supporting regulatory submissions.

Job Responsibilities

•Responsible for the preparation and peer review of quality regulatory submissions for various markets to ensure timely approval  
Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.
•Accountable for assessing, coordinating and compiling deficiency responses in a timely manner.
•Works with other functional areas to resolve issues related to information for regulatory submissions.
•Prepare and peer review labelling, product monographs and marketing materials.
•Evaluate, prepare and peer review of post approval supplements to manage the regulatory product life cycle as applicable.
•Review of change control documents.  
•Approval of change control documents and quality notifications as assigned.
•Assist in product launch activities as required.
•Maintains regulatory databases to ensure accuracy of information.
•Works in a safe manner collaborating as a team member to achieve all outcomes.
•Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
•Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.  
•All other relevant duties as assigned.

Job Requirements

oMinimum BSc degree or equivalent in Chemistry or Pharmacy or Life Sciences.
oDiploma from a RA program would be an asset.
•Knowledge, Skills and Abilities
oFamiliairty with multiple regulatory requirements  e.g., TPD, EU, TGA, etc.
oAttention to detail
oComputer literate. (Proficiency with MS Office specifically)
oMinimum 3-5 years pharmaceutical experience in an RA role
oGood oral / written communication, organizational and interpersonal skills.



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 – Research & Development https://ift.tt/39PZXQl

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.