About This Opportunity: Canada - Lead RPM - Regulatory Project Manager (Saint-Antoine-sur-Richelieu)
Freyr Solutions is currently seeking a Canada - Lead RPM - Regulatory Project Manager (Saint-Antoine-sur-Richelieu) to join their team in Saint-Antoine-sur-Richelieu.
This position offers an excellent opportunity for motivated individuals looking to advance their career.
Education Requirements
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No specific education requirements
Required Experience
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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
Position Details
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Employment Type: life balance.
Continuous learning and professional development opportunities.
Collaborative and inclusive work culture that values diversity.
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
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Location: Saint-Antoine-sur-Richelieu
Key Responsibilities
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Effectively perform assigned job duties
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Maintain safety and cleanliness in the workplace
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Work effectively with team members
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Follow company policies and procedures
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Perform tasks according to quality standards
Qualifications
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Reliability and punctuality
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Ability to work independently and in a team
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Strong work ethic and positive attitude
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Ability to follow instructions
Why Join Freyr Solutions?Freyr Solutions offers a supportive work environment in Saint-Antoine-sur-Richelieu, where employees can grow and develop their skills. This Canada - Lead RPM - Regulatory Project Manager (Saint-Antoine-sur-Richelieu) position provides the opportunity to work with a dedicated team and contribute to meaningful work.
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