Associate Director Regulatory Affairs

Posted
Ottawa, ON, (View Map)
  • Company
    Abbott Laboratories
  • Job Type
    Please Contact

Description

We're looking for a candidate to fill this position in an exciting company.
  • Execute and manage technical and scientific regulatory activities.
  • Must function independently as a decision-maker on regulatory issues and must assure that deadlines are met.
  • Effectively communicate, prepare and negotiate both internally and externally with various regulatory agencies.
  • Properly interpret and apply regulatory requirements.
  • Interfaces with a variety of management levels on significant matters, often requiring the coordination activity across organizational units.
  • May lead a cross-functional or cross-divisional project team.
  • Provides technical leadership to business units.
  • Knowledge of principles and requirements of promotion, advertising and labeling.
  • Knowledge of international treaties and regional, national, local and territorial trade requirements, agreements and considerations.
  • Knowledge of domestic and international regulatory guidelines, policies and regulations and ethical guidelines of the regulatory profession, clinical research and regulatory process.
  • Broad knowledge of various technical alternatives and their potential impact on the business.
    • Minimum 7 years’ relevant experience in a regulated industry.
    • Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
    • Regulatory agency structure, processes and key personnel.
    • Principles and requirements of applicable product laws.
    • Submission/registration types and requirements.
    • GxPs (GCPs, GLPs, GMPs).
    • Principles and requirements of promotion, advertising and labelling.
    • Domestic and international regulatory guidelines, policies and regulations (including Europe).
    • Ethical guidelines of the regulatory profession, clinical research and regulatory process.
    • Drive gap analysis for new regulations.
    • Bachelor’s degree
    • Excellent English communication skills;
    • Strong organizational skills with a proven ability to drive for results;
    • 5-8 years of experience in a similar role, preferably within medical device/diagnostics industry.
    • Experience working in a broader enterprise/cross-division business unit model preferred.
    • Ideally candidate has submission experience with FDA or Health Canada.

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      Abbott Laboratories
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