Regulatory Affairs Project Manager

2 weeks ago

Mississauga, Ontario, Canada Juno Pharmaceuticals Full time
Regulatory Affairs Project Manager

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:
  1. Manage assigned Regulatory Affairs projects independently and collaborate with other staff or consultants as needed to ensure successful project outcomes.
  2. Review technical dossiers/packages for accuracy, completeness, and compliance with Regulatory requirements, and prepare gap reports as necessary.
  3. 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.
  4. Build and maintain healthy working relationships with Regulatory Agencies, leveraging these relationships to understand expectations beyond those presented in guidelines and policy statements.
  5. Organize and facilitate meetings and teleconferences to maintain project progress, track critical attributes, and ensure accountability and efficiency.
  6. Resolve technical queries or deficiency letters relating to submissions in a timely manner within deadlines.
  7. Collaborate with senior decision-makers to provide technical direction and prepare Regulatory strategies for new products under assessment.
  8. Provide regulatory counsel to ensure compliance with regulations, and offer cross-functional input from an operational, scientific, and technical viewpoint.
  9. Monitor regulatory maintenance of approved drug products, maintain current awareness of regulatory guidelines, and review Change Controls to determine filing requirements.
  10. 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).
  11. Perform other regulatory affairs functions and activities as assigned to achieve departmental or operational priorities, and prioritize other responsibilities to meet additional work requirements.
  12. Build and maintain healthy working relationships with business partners, and contribute to an efficient and effective regulatory affairs team.
  13. Regulatory Affairs Certification and/or a minimum of 5 years relevant experience in pharmaceutical Regulatory Affairs with Health Canada are required.
  14. Regulatory Affairs experience with FDA is an asset.
  15. Detail-oriented, superior problem-solving ability, planning, analytical, and organizational skills to manage multiple concurrent projects within established timelines are essential.
  16. 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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