NEW JOB POSTING: Regulatory Affairs Project Manager

NEW JOB POSTING : Regulatory Affairs Project Manager

Regulatory Affairs Project Manager

Position Overview :

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.

Responsibilities :

• Effectively manage assigned Regulatory Affairs projects independently and when needed incorporate the assistance of other staff or consultants to ensure a successful conclusion.
• Review, evaluate, prepare and submit submission to Health Canada and / or the US FDA.
• 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.
• Review, evaluate, prepare and submit responses to Health Canada and FDA requests for clarification / letters of deficiency.
• 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.

and share knowledge with the department. 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.
• Support provincial formulary submissions and drug product listing in co-ordination with Sales and Marketing department.
• Contribute to an efficient and effective regulatory affairs team.

Job Requirements :

• University Degree, B.Sc. or higher in Chemistry or Health Sciences.
• 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.
• Excellent communication (oral and written) and influencing skills; able to interact effectively and confidently both internally and externally.
• Proactive with self-discipline and competitive drive
• Strong interpersonal skills with ability to work effectively and efficiently.
• Strong computer skills including Microsoft Office Suite and Adobe Acrobat.

Reports to : Regulatory Affairs Manager

How to Apply :

Please send us an email with your resume to [email protected]

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