Job Description

The Position



Job Title: Pharmacy Residency

Division: Pharma

Department: Global Product Development Regulatory (PDR)

Location: Mississauga

Position Purpose

To gain insight and experience working in Product Development Regulatory. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry.

Pharmacy Residents are expected to perform their responsibilities with considerable supervision. They are expected to work cross-functionally and help coordinate regulatory-related activities across the PDR ecosystem and with other internal partners.

Your Key Responsibilities

Prepares a major research project on an identified issue or question of relevance to the Industry as a joint collaboration between the Company (Roche) and the University of Toronto.

Participates in the development and implementation of global and local innovative regulatory strategies including Health Authority interactions for the development and license maintenance of Roche Medicines as assigned.

Prepares (writes or substantively edits) clinical and pharmacovigilance regulatory documents in accordance with applicable regulatory guidelines/Roche standards/SOPs, ensuring high scientific quality and consistency with other documents where appropriate.

Participates in and supports the process for timely development, maintenance and revisions of the product labeling for pharmaceutical products and devices, including coordinating preparation of documentation packages supporting proposed Core Data Sheet (CDS) or local labeling changes.

Plans, compiles, publishes, submits, and archives regulatory submissions, in compliance with health authority regulations worldwide.

Provides guidance on regulatory procedures and requirements to product teams.

Researches and supports development of regulatory strategic options and assessments of risk for business critical decisions.

Participates in new filings (e.g. new indications, new formulations) based on business needs and/or global Health Authority requirements, as appropriate.

Obtains and applies knowledge of Roche and regulatory guidelines, procedures and best practices across relevant documents.

Participates as a member of key functional/cross-functional team(s) (e.g. Regulatory Affairs Functional Team, Study Management Team, Global Filing Team, etc.), ensuring that teams adequately plan for filing and maintenance activities.

Assists with building and maintaining regulatory process networks, monitoring benefit realization and maintaining the regulatory business process management framework.

Actively contributes to strategic initiatives, best practices and continuous improvement within PDR.

Stays informed of regulatory guidance and scientific & medical issues important to drug development, assigned products, and disease/therapeutic areas.

Who You Are

You hold a Degree in Pharmacy (Bachelor of Pharmacy or PharmD).

You possess high-quality written and oral communication skills.

You are able to independently analyze and synthesize data from a broad range of disciplines.

You possess strong project management skills to plan and consistently deliver on multiple tasks and goals on-time.

You have good interpersonal and verbal communication skills.

You are able to work effectively in a team environment and establish strong collaborative relationships

The statements made in this job description are intended to describe the general nature and level of work being performed by those persons assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

This position is not eligible for relocation support.

The Industrial Pharmacy Residency Program (IPRP) is administered by the Leslie Dan Faculty of Pharmacy, University of Toronto and is geared for those who are part of this program.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche\'s truly innovative culture.

As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.

Roche is an Equal Opportunity Employer.

Roche