Regulatory Affairs Project Lead
3 weeks ago
A Regulatory Project Manager at Juno Pharmaceuticals coordinates and manages assigned Regulatory Affairs projects to ensure successful growth and maintenance of the company's product portfolio in a fast-paced and rewarding environment.
Key Responsibilities include:
• Effectively manage assigned Regulatory Affairs projects independently and, when needed, collaborate with other staff or consultants to ensure a successful conclusion.
• Review technical dossiers/packages for accuracy, completeness, and compliance with regulatory requirements and prepare gap reports.
• Ensure that submissions meet format and content requirements and guarantee the accuracy and completeness of statements, data, and conclusions in reports and summaries for inclusion in Regulatory submissions.
• Build and maintain healthy working relationships with Regulatory Agencies, using these relationships to understand expectations beyond those presented in guidelines and policy statements.
• Organize and facilitate meetings and teleconferences to maintain progress of projects, track critical attributes of projects to ensure accountability and efficiency, and resolve any technical queries or deficiency letters relating to any submission in a timely manner within deadlines.
• Collaborate with senior decision-makers to provide technical direction and prepare Regulatory strategies for new products under assessment.
• Provide regulatory counsel to ensure that all activities comply with regulations and provide cross-functional input from an operational, scientific, and technical viewpoint.
• Monitor regulatory maintenance of approved drug products, maintain current awareness of regulatory guidelines (Health Canada, ICH, EMEA, FDA, etc.), review Change Controls, and determine filing requirements.
• Review and approve product labeling to meet regulatory requirements and review promotional material to ensure compliance with Health Canada regulations, PAAB guidelines, and/or ASC guidelines (as applicable).
• Perform other regulatory affairs functions and activities as assigned to achieve departmental or operational priorities and prioritize other responsibilities to meet additional work requirements.
Reports to: Regulatory Affairs Manager
How to Apply:
Please submit your resume to careers@junopharm for consideration.
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