Regulatory Program Director Lead

5 days ago


Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full time

Overview

F. Hoffmann-La Roche Gruppe is a global healthcare leader with a strong presence in Canada, where we employ over 850 employees at our Mississauga facility.

We are committed to innovation, curiosity, and diversity, which has enabled us to become one of the world's leading research-focused healthcare groups.

The Opportunity

We are seeking a highly skilled Regulatory Program Director to join our Pharma Technical Regulatory (PTR) team in Mississauga, Ontario.

This role will be accountable for handling all Health Authority interactions pertaining to CMC Information, as well as informational and pre-submission meetings with global Health Authorities, partners, and industry experts.

About the Role

As an Associate Regulatory Program Director, you will be responsible for submitting high-quality CMC regulatory documents to health authorities globally according to current Good Manufacturing Practices (cGMP), Roche corporate standards, and the requirements of applicable health authorities and other regulatory agencies.

You will also ensure compliance and accuracy of data in regulatory documents and information management systems, as well as oversee timely responses to Health Authority questions received from major/global regulators.

Requirements

To succeed in this role, you will need a Bachelor's Degree in life science disciplines with a minimum of 5 years of industry experience in technical regulatory CMC, such as manufacturing or quality-related fields in the pharmaceutical/biotechnology industry.

You should have experience in developing global regulatory strategies and scenario planning with robust regulatory risk assessment, as well as technical understanding of drug substance, product manufacturing, critical quality attributes, control system, process changes, and comparability in biologics.

Salary and Benefits

We offer a competitive salary range of $120,000 - $180,000 per annum, depending on experience, as well as relocation benefits, comprehensive health insurance, and a generous pension plan.

How to Apply

Please submit your application, including your resume and cover letter, to us via email.



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