Canada - Lead RPM - Regulatory Project Manager - vaughan, Vaughan

Lead Regulatory Project Manager Location: Remote Job Type: Permanent/FTE Position Overview Key Responsibilities - Partner with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for high‑complexity programs/products are established and executed seamlessly. - Expertly lead cross‑functional project submission working groups (SWGs) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for complex, novel, and critical programs. - Provide expert project management leadership, oversight, direction, and planning. - Directly support the program GRL by ensuring project management and regulatory operational support for the asset. - Perform regulatory operational activities and oversee vendors providing operational support for assigned programs. - Provide additional support as required. Minimum Requirements Education - Bachelor’s or Master’s degree in Pharma/Medical or another associated scientific discipline OR equivalent. Experience - Minimum 10 years in the Regulatory field and 5+ years of demonstrated project management skill sets. - Expertise with project management software and tools, e.g., MS Project, SharePoint, OneNote. Additional experience with OnePager and Office Timeline preferred. - Proven experience driving submissions for major markets (e.g., US IND, NDA, BLA, EU MAA, EU variations). - At least one major (original or supplement) and several minor (amendment) filing experience in one or more jurisdictions. - Experience with eCTD and submission timeline management is required. Skills - Strong conceptual and analytical thinking skills. - Deep understanding of global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology, and process. - Proficiency in MS Office (Word, Excel, Outlook). - Ability to multitask, prioritize competing assignments, and work under deadlines in a fast‑paced environment. - Excellent verbal and written communication skills; ability to prepare effective presentations with focused messaging. - Demonstrates strong collaboration and interpersonal skills with the ability to work across departments and external organizations. - Fluency in English (written, verbal, reading). What We Offer - Competitive salary and benefits package. - Flexible work environment (remote or hybrid options available). - Opportunity to work with a global team and contribute to impactful projects. - Continuous skilled growth through training and development programs. - Inclusive, team‑oriented, and innovative work culture. Apply on Kit Job: kitjob.ca/job/2psh9t