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

Provides regulatory expertise to internal and external stakeholders in support of the drug product and packaging component changes of marketed products across global Apotex sites.  Regular liaison with team members and other functional groups to assess complex issues and propose/implement process improvements

Job Responsibilities

•Global RA lead in managing drug product changes for marketed products across global Apotex sites.
•Global RA lead for Packaging component changes for marketed products across global Apotex sites
•Providing regulatory strategy and impact for global drug product and packaging component related changes.
•Liaising with regulatory teams across global sites to develop a common process for managing drug product and packaging component related changes.
•Reviews work conducted by team members to ensure accuracy, quality & compliance of information (i.e. dossiers, reports etc.).
•Acts as a point person and lead for site specific PLCM issues.
•Assists the Manager in the development of regulatory solutions when conducting impact analysis for PLCM projects.
•Evaluates issues/problems, proposes solutions and implements action plans/process improvements, informing and escalating as appropriate. Works with other functional areas to resolve issues related to regulatory submissions, compliance, and internal processes
•Provides training to team members to support the preparation of quality submissions, and other functional tasks.
•Coordinates and completes special projects as assigned.
•Acts as a designate to the Manager as required.
•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.
•Knowledge, Skills and Abilities
oDetailed knowledge of multiple regulatory requirements  e.g., TPD, EU, TGA, etc.
oAbility to effectively cmmunicat with Senior Level leadership
oAbility to manage multiple concurrent projects
oFamiliarity with IT systems, e.g. databases and various software packages.
oMinimum five years experience in the pharmaceutical industry
oMinimum three years experience in senior Regulatory Affairs role.
oExperience in leading/managing Project Teams



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/2sanomG

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.