Regulatory Affairs Associate

Apotex Inc. - North York, ON (il y a 30+ jours)

Postuler dès maintenant

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.

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.
Interact with other applicable departments within Apotex to discuss and provide solutions to regulatory issues and problems.
Communicate with external sources such as agents and suppliers to request and provide data relevant to submissions.
Resolve complex issues relating to submissions.
Interprets and makes decisions relating to regulatory guidelines and policies.
Addresses complex regulatory activities in support of submissions.
Assist in training of more junior staff.
Interpret and ensure compliance with SOPs, RA policies and procedures and regulatory guidelines.
Prepare and draft SOPs and regulatory guidelines.
Job Requirements

BSc degree or equivalent in Chemistry, Pharmacy or Life Sciences. Diploma from a RA program would be an asset.
Minimum 3 years’ experience in post-marketing regulatory affairs within the pharmaceutical industry is required for this role.
Experience with DocuBridge, SAP and TrackWise.
Good oral / written communication, organizational and interpersonal skills.
Attention to detail.
Demonstrates leadership skills.
Computer literate. (Proficiency with MS Office specifically).
COVID-19 Update

We have adapted our recruitment strategy to ensure our staff and applicants are safe by conducting our interviews and onboarding online.

Other measures Apotex has put into place include (but are not limited to):

staggering employee shifts to reduce the size of work groups
modifying our cafeteria space to enhance social distancing, the implementation of additional cleaning and sanitization routines
robust self-assessment and screening tools
non-surgical masks for employees working in GMP areas
travel restrictions
work-from-home policy for all employees who can perform their roles remotely
strict visitor screening protocol

It is important to note that while these are our protocols at this time, they are subject to change based on guidelines and regulations put in place by local and global government agencies.

For up-to-date information about Apotex’s ongoing efforts in response to COVID-19, visit: https://www1.apotex.com/global/covid-19-update or follow us on LinkedIn and Twitter

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.