Regulatory Affairs Project Manager F/H
4 weeks ago
Regulatory Affairs Project Manager Regulatory Affairs Project Manager
A Regulatory Project Manager at Juno Pharmaceuticals effectively prepares and manages assigned Regulatory Affairs projects to ensure successful growth and maintenance of the Juno product portfolio in a fast paced, sociable, upbeat and rewarding environment.
Effectively manage assigned Regulatory Affairs projects independently and when needed incorporate the assistance of 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 requirement as well as ensure the accuracy and completeness of statement, data and conclusion in reports and summaries for inclusion in Regulatory submissions.
• Build and maintain a healthy working relationship with Regulatory Agencies. Use the relationship to understand expectations beyond that which is 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.
• 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. 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 labelling to meet regulatory requirements. Review promotional material to ensure compliance to 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 prioritizes other responsibilities to meet additional work requirements
• Build and maintain a healthy working relationship with business partners.
• Contribute to an efficient and effective regulatory affairs team.
Regulatory Affairs Certification and/or a minimum of 5 years relevant experience in pharmaceutical Regulatory Affairs with Health Canada
• Regulatory Affairs experience with FDA an asset
• Detail oriented, superior problem-solving ability to identify solutions, planning, analytical and organizational skills to manage multiple concurrent projects within established timelines.
• Strong computer skills including Microsoft Office Suite and Adobe Acrobat.
Reports to: Regulatory Affairs Manager
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