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Mgr/Sr Manager, Regulatory Affairs (Oncology)

Req #: 1700990
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: Regular
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 Manager/Senior Manager, Regulatory Affairs is responsible for the development of local regulatory strategy to ensure product approvals for Celgene’s myeloid and oncology compounds within optimal timelines. The Manager or Senior Manager, Regulatory Affairs leads the preparation, review, and submission of regulatory dossiers to Health Canada for approval of new products and indications. The Manager or Senior Manager, Regulatory Affairs acts as the Canadian Regulatory lead for the creation of regulatory dossiers and works with international project teams to deliver all necessary submission components. This individual also operates as a subject matter expert to cross-functional local teams and global business partners, effectively communicating local strategies, risk mitigation measures, and progress.

Duties and Responsibilities

Develop and Implement Regulatory Strategy for Myeloid Pipeline

  • Determines and implements optimal regulatory strategy for new products/ new indications within the hematology franchise with consideration for the needs of patients, prescribers, payers, Health Canada and Celgene
  • Coordinates efforts and effectively communicates with global regulatory strategy leader to ensure alignment of priorities and strategies
  • Prepares and coordinates the creation of regulatory submissions (NDS, SNDS, NC) to agreed upon target dates and manages the response to Health Canada information requests
  • Anticipates any delays in pre-defined submissions, finds the root cause, sets up corrective action plan and/or proposes alternate solutions
  • Represents Regulatory Affairs at cross-functional therapy team meetings and effectively communicates Regulatory objectives and progress. Contributes to brand strategy
  • Maintains an effective working relationship with Health Canada throughout the product lifecycle leading to prompt regulatory approval and optimal labeling outcomes
  • Prepares briefing packages and creates strategy for pre-submission meetings and responses to Health Canada requests pertaining to the assigned products/teams
  • Collaboratively negotiates with internal and external stakeholders to ensure productive discussion and maximum benefit for all parties
  • Proactively monitors the latest regulations, guidance, and precedents from Health Canada, PAAB and competitors that may influence the regulatory landscape
  • Reviews product labeling/advertising to ensure compliance with federal regulations and internal standards
  • Organizes the compilation of an entire Regulatory submission. Participates, as required, in authoring of documents/summaries, review and approval, and provides editorial review for all components of regulatory applications and submissions
  • Works co-operatively with Regulatory Operations to ensure timely submissions to Health Canada

Regulatory Affairs Team Member

  • Acts as reviewer and editor, as required, for NDS/SNDS/Notifiable Change submissions outside own therapeutic area
  • Interprets Health Canada policies and guidelines. Provides feedback during consultation period for new/revised policies
  • Seeks opportunities to apply continuous improvement to internal procedures and practices
  • Understands and possesses the courage to challenge scientific arguments
  • Participates in Regulatory Affairs department initiatives
  • Researches disease areas of company focus. Summarizes Canadian drug approvals within a therapy area  
  • Other tasks as assigned

Required Competencies

The Manager/Senior Manager, Regulatory Affairs is the primary point of contact between Canadian Regulatory Affairs and Commercial, Medical Affairs, Supply Chain, Market Access, clinical study teams and Global counterparts for assigned products

Knowledge, Skills, and Abilities:

  • Proven experience in the preparation of New Drug Submissions, Supplemental New Drug Submissions and Notifiable Changes
  • Advanced scientific writing skills
  • Thorough knowledge of the drug development and commercialization process
  • 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, negotiation and influencing skills
  • Demonstrated understanding of the Food & Drug Act, Health Canada guidelines, processes and issues in drug/biologics development
  • 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, MSc, PhD, PharmD)
  • Minimum 5 years related experience in pharmaceutical Regulatory Affairs or related field
  • Demonstrated experience preparing New Drug Submissions for submission to Health Canada and implementing regulatory affairs strategies.
  • Sr. Manager level requires demonstrated experience successfully leading and developing complex regulatory affairs strategies, and successfully leading and managing organizational change related to regulatory affairs.

Competencies:

  • Customer Focus
  • Strategic Perspective
  • Drives Execution & Acts Quickly
  • Technical/Professional Knowledge
  • Inspires & Motivates
  • Decision Making
  • 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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