Project Manager, New Product Development (Regulatory Affairs) Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

Responsible for leading Recent Product Development (NPD) submission activities, including but not limited to, due diligence activities for new product opportunities, new product development submissions, and associated activities such as deficiency responses. Strong linkages need to be established with internal colleagues and development partners. Leads development of strategies and operations for projects under the NPD portfolio within GRA.

Develops regulatory project strategy with appropriate risk mitigation strategies incorporated Ability to recover projects that are at risk Prepares/leads regulatory submissions according to current requirements, and taking into account current deficiency trends Leads development of optimal deficiency response strategies with internal and external stakeholders; Conducts thorough due diligence of opportunities brought forward by the Business Development team, and identifies all regulatory risks associated with the potential opportunity; if not provided with initial data package from the partner, requests for key elements required to conduct the thorough assessment,



based on status of the development/submission for the opportunity. Executes change control assessments, and any subsequent activities required as a result of the assessment (regulatory submissions, database updates) Trains and provides guidance to peers as required Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. in chemistry, biology, pharmaceutical, engineering, health sciences or a related field required. Must possess strong knowledge of regulatory requirements associated with new drug submissions , and have familiarity with technical/quality aspects associated with these products Excellent conflict management skills ability to work independently and manage priorities Demonstrated knowledge of the generic new product development process Knowledge of Canadian and US regulatory guidelines a must Knowledge of and experience with the MS-Office suite of products ~ 8+ years progressive experience the pharmaceutical regulatory affairs We offer accommodation for applicants with disabilities as part of its recruitment process.

The hiring range for this position is $ 95,594.40- $ 133,832.16 CAD per year. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and career development.

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📌 Project Manager, New Product Development (Regulatory Affairs) (Toronto)
🏢 APOTEX
📍 Toronto