Regulatory Site Officer

Sanofi•Toronto, ON

2d•Onsite

About The Position

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. The Quality Compliance and Regulatory Team is part of Site Quality Operations supporting the Manufacturing & Supply organization in Toronto. The Quality Compliance and Regulatory teams oversee site compliance programs, self-inspection, quality risk management and regulatory dossier management (chemistry, manufacturing & controls and facilities) in alignment with regulatory requirements and Sanofi standards. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives

Requirements

Minimum of a bachelor’s degree; advanced degree (Masters, PhD) in a science/health field is preferred.
At least 2-4 years of Regulatory Affairs CMC experience, or combination of experience in a Quality role, in the pharmaceutical/biologics industry.
Experience working for a Regulatory Health Authority an asset.
Strong verbal and written communication skills to prepare accurate, clear, and comprehensive CMC dossiers; able to effectively communicate with internal and external audiences.
Self-motivated, detail oriented and results driven with excellent organizational ability.
Strong site and customer focus with ability to prioritize/adapt to changing business and manufacturing needs.
Strong problem-solving skills with ability to overcome risks/constraints.
Strong self-awareness and ability to understand role's impact/influence, as well as decision making ability.

Nice To Haves

Advise how to write CMC dossiers and responses to health authority queries.
Decide for which changes a regulatory strategy must be established and provide the information to site operations.
Review regulatory strategies defined by GRA for changes linked to site products.
Advise and execute the regulatory compliance maintenance program for the site products.
Advise on audit preparation and follow-up action

Responsibilities

Authoring variations, CTD sections impacted by the changes and the renewals for registered products, territory extensions, in compliance with all applicable regulations and company processes.
Maintaining and updating regulatory files and databases.
Define the potential regulatory impacts of changes made to a group of products and services.
Ensuring compliance of a group of products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates.
Support regulatory inspections and audits, providing regulatory support and documentation.