Executive / senior industry position
Sr. Associate, GRA - PLCM(US, Canada, ROW)
About Apotex Inc.
Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.
Responsible for the product life cycle management of Apotex products (Toronto) in identified markets (US, Canada, International markets etc.).
- Responsible for providing support and regulatory guidance to a team of RA Associates in the completion of projects supporting regulatory submissions.
- Responsible for the preparation of quality regulatory PLCM 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.
- Responsible for handling the Supplier driven changes (SDC). This involves activities such as evaluate, prepare & review of SDC related assessments.
- Evaluate, prepare and 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.
- Maintains regulatory databases to ensure accuracy of information.
- Perform additional duties as assigned by RA Manager.
- Works as a member of a team to achieve all outcomes.
- Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion, Demonstrates strong and visible.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- All other duties as assigned.
- M. Pharm or other equivalent health science, scientific qualification
- 5+ years Regulatory Affairs experience (Licence Maintenance / Product Life cycle Management) in Prescription Medicines preferably in US, Canada, International markets
- Good verbal & 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.