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Associate Manager, Regulatory Affairs (Contract)

Req #: 1700989
Location: Mississauga, ON CA
Job Category: Regulatory Affairs
Work Location: 6755 Mississauga Road Suite 600 MISSISSAUG L5N 7Y2
Organization: Celgene Inc.
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Fixed Term
Job Level:
Travel:
Other Locations:Canada- ON- Mississauga

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

The Associate Manager, Regulatory Affairs (Contract) is responsible for the preparation, review, and submission of regulatory dossiers to Health Canada to ensure regulatory compliance and strategic benefit. The Associate Manager submits clinical trial documentation to Health Canada over the lifespan of the clinical program including Clinical Trial Applications, Amendments and Notifications across the breadth of Celgene’s diverse and innovative drug development pipeline. The Associate Manager is also the Regulatory lead for non-promoted products, ensuring Product Monographs remain in compliance with company core data sheets through the preparation and filing of Supplemental New Drug Submissions/ Notifiable Changes/ Annual Notifications, as required.

Duties and Responsibilities:

Submit Clinical Trial Applications, Amendments and Notifications to Health Canada

  • Primary point of contact between Canadian Regulatory Affairs and the clinical study teams
  • Prepares and coordinates the creation of Clinical Trial Applications, CTA-Amendments, and CTA-Notifications. Participates, as required, in authoring, review and approval of documents
  • Facilitates the authoring, or gathering, of components of the submission within pre-defined schedules in accordance with RA procedures. Completes the Protocol Safety and Efficacy Assessment Template (PSEAT) for CTAs
  • Reviews protocol concept sheets for alignment with Canadian requirements and strategy. Solicits comments from cross-functional team members
  • Acts as point person for Health Canada interactions including organizing responses to Information Requests (Clarimails)
  • Acts as local Regulatory point of contact for Clinical Operations
  • Reviews clinical trial documents received from clinical study teams for completeness
  • Recommends appropriate course of action to file Chemistry, Manufacturing and Control changes
  • Ensures Regulatory compliance for all new investigator initiated, co-operative group, and business partner clinical trials
  • Files Clinical Trial Site Investigator (CTSI) forms with Health Canada
  • Performs quality review of all documentation submitted to Health Canada
  • Works co-operatively with Regulatory Operations to ensure timely submission to Health Canada
  • Reviews content of clinical trial labels for accuracy and alignment with the Food and Drug Act

Manages Regulatory Responsibilities for Non-Promoted Products

  • Acts as primary contact point between Regulatory and other functions for non-promoted products
  • Ensures approved labelling remains in compliance with Company Core Data Sheets through the submission of SNDS/NC/Annual Notifications
  • Makes judgments and decisions based on Health Canada regulations and professional experience
  • Coordinates the response to Health Canada information requests through collaborative interactions with subject matter experts
  • Communicates the status of labelling changes to stakeholders

Regulatory Affairs Team Member

  • Prepares, reviews and submits SNDS/Notifiable Changes for marketed products
  • Submits Annual Notifications (Level 3 changes) for all marketed products and maintains records for Level 4 changes
  • Reviews major submissions for alignment with content plan and Health Canada guidances
  • Leads bi-monthly departmental submission planning meeting
  • Maintains submission dashboard detailing the status of planned and ongoing departmental submissions
  • Researches disease areas of company focus. Summarizes Canadian drug approvals within a therapy area  
  • Requests Certificates of Pharmaceutical Product from Health Canada and arranges for legalization and notarization
  • Coordinates the French translation of clinical trial labels, Product Monographs and other essential regulatory documents
  • Maintains awareness of regulatory commitments to Health Canada
  • Coordinates the development and implementation of new and revised artwork
  • Assists senior Regulatory staff in the preparation of documents
  • Act as Regulatory representative for interface with local Quality Operations
  • Other tasks as assigned

Required Competencies-Knowledge, Skills, and Abilities:

  • Advanced knowledge of Health Canada’s Clinical Trial Application process for both small molecules and biologics
  • Proven expertise in preparing eCTD and non-eCTD, routine and non-routine, and complex regulatory submissions to Health Canada
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target accomplishment of tasks
  • Advanced interpersonal, verbal communication and influencing skills
  • Demonstrated understanding of Health Canada guidelines, processes and issues in drug/biologics development. Includes sound knowledge of GCP (Good Clinical Practice) and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat

Education and Experience:

  • Degree in a relevant scientific discipline (e.g. BSc, RN, PharmD) preferred
  • Minimum 2 years related experience in pharmaceutical Regulatory Affairs or related field
  • Demonstrated experience preparing Clinical Trial Applications

Competencies

  • Initiative
  • Technical/Professional Knowledge
  • Action Oriented
  • Decision Making
  • Customer Focus
  • Building Relationships
  • Project Management

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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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