Associate Regulatory Risk Management

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City : Toronto

Category : Regulatory Affairs

Industry : Consumer Goods

Employer : Johnson & Johnson

Janssen Inc., a member of the Johnson & Johnson Family of Companies, is currently seeking an Associate, Regulatory Risk Management for a 1-year Contractual Position to be based in Toronto, Ontario.

As a member of the Johnson & Johnson Family of Companies, Janssen Inc. is the pharmaceutical sector and is dedicated to addressing and solving the most important unmet medical needs in oncology, immunology, infectious diseases and vaccines, neuroscience, metabolic diseases, and women’s health. Driven by our dedication to the hardworking pursuit of science for the benefit of patients, we work together to bring creative ideas, products and services to patients around the world.

As part of the Regulatory, Quality, Marketed Products Risk Management, and Safety (RQMS) Division at our Toronto, Ontario location, the contractual Associate, Regulatory Risk Management works in collaboration with Drug Regulatory Affairs and Drug Safety & Surveillance to prepare Health Canada compliant drug product Risk Management Plans (RMPs) across multiple therapeutic areas.  Regulatory Risk Management also contributes to the development of surveillance and risk mitigation activities under RMP commitments, including educational initiatives, post-market studies, and market surveys.

In this role, you will:

  • Plan, prepare, deliver and maintain drug product Risk Management Plans (RMPs) and Canadian Addenda in compliance with Health Canada requirements and in alignment with the company’s business objectives
  • Liaise with drug Regulatory Affairs to assess requirements for RMPs to support regulatory submission activities
  • Collaborate with local and global cross-functional teams on the development of risk mitigation strategies and activities
  • Coordinate and track the implementation of risk management programs with all contributing departments to ensure adherence to deliverables and timelines proposed in regulatory submissions
  • Contribute to the assessment of effectiveness in risk mitigation activities
  • Review safety documentation, including Periodic Safety Update Reports (PSURs) and Company Core Data Sheet (CCDS) updates to assess impact of any changes to these documents on the risk management strategies for planned RMPs
  • Support the preparation of responses to Health Canada questions about RMPs and related safety issues, including Issue-related Summary Reports (IRSRs) to meet all Canadian regulatory requirements
  • Contribute to company and industry association policy activities to shape the Canadian regulatory environment for RMPs and post-market safety requirements

  • Minimum B.Sc. in a relevant scientific or medical field) is required
  • A degree in Pharmacy, Nursing or a health-related field would be an asset
  • Minimum of 1 year of relevant experience in pharmaceutical Regulatory Affairs is required
  • Additional education or experience in Regulatory Affairs is an asset
  • MSc, Ph.D. or Pharm D in a relevant scientific or medical field would be an asset
  • Strong scientific or medical writing skills, with experience authoring regulatory, clinical and/or drug safety documents is required
  • Background in clinical/epidemiological research, pharmacovigilance, or pharmacokinetics would be an asset
  • Ability to interpret and summarize clinical data and to synthesize arguments is required
  • Well-developed project management skills is required
  • Well-developed team skills is required
  • Ability to manage multiple priorities and deadlines is required
  • Strong negotiation and influencing skills is required
  • Problem solving and analytical skills are required
  • Excellent communication skills are required (written and verbal, including presentation skills)
  • An understanding of data analysis methodology or biostatistics would be an asset
  • Experience in authoring of scientific publications would be an asset
  • Therapeutic area knowledge in immunology, oncology, infectious diseases, neuroscience, or metabolic diseases an asset

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.

Primary Location
Janssen Inc. (7710)
Job Function
Regulatory Affairs
Requisition ID

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