Regulatory Affairs Project Manager
2 weeks ago
Job Summary:
A Regulatory Affairs Project Manager at Juno Pharmaceuticals is responsible for effectively preparing and managing assigned Regulatory Affairs projects to ensure successful growth and maintenance of the Juno product portfolio in a fast-paced environment.
Key Responsibilities:- Manage assigned Regulatory Affairs projects independently and collaborate with other staff or consultants as needed to ensure successful project outcomes.
- Review technical dossiers/packages for accuracy, completeness, and compliance with Regulatory requirements, and prepare gap reports as necessary.
- Ensure that submissions meet format and content requirements, and verify 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, leveraging these relationships to understand expectations beyond those presented in guidelines and policy statements.
- Organize and facilitate meetings and teleconferences to maintain project progress, track critical attributes, and ensure accountability and efficiency.
- Resolve technical queries or deficiency letters relating to submissions 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 compliance with regulations, and offer cross-functional input from an operational, scientific, and technical viewpoint.
- Monitor regulatory maintenance of approved drug products, maintain current awareness of regulatory guidelines, and review Change Controls to 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.
- Build and maintain healthy working relationships with business partners, and 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 are required.
- Regulatory Affairs experience with FDA is an asset.
- Detail-oriented, superior problem-solving ability, planning, analytical, and organizational skills to manage multiple concurrent projects within established timelines are essential.
- Strong computer skills, including Microsoft Office Suite and Adobe Acrobat, are required.
Reports to: Regulatory Affairs Manager
How to Apply:
Please send your resume to careers@junopharm.
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