Director, Regulatory Affairs

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Job Type
Permanent position
Job number
Spoken and written languages
Français, English
Used softwares
Suite Office


The candidate will be responsible for the formation of the global regulatory strategy involving the direction and management of resources and activities in the development and implementation of regulatory strategies leading to the rapid submission and approval of dossiers meeting the requirements of Health Canada and FDA and the needs of the company.

Main Responsibilities

  • You will be responsible for the preparation, filing and maintenance of filings for CTAs/INDs ANDS, NDS, DINAs, Labelling standards, etc., according to existing guidelines and corporate objectives.
  • As the most senior person in regulatory affairs, your role will also include representing company on all Regulatory matters with the various Regulatory Inspectorates including responding to Clarifaxes, Notice of Deficiency (NOD) and Notice of Non-Compliance (NON)
  • You will be responsible in elucidating the Regulatory path for all new in-licensing and in house development programs
  • You will provide guidance and coaching to the Regulatory Affairs Associates on all Regulatory and Market Access matters




Specific knowledge

  • Must have B. Sc. Degree in Pharmacology, Biochemistry and/or relevant specialties
  • Minimum five (5) years of experience in the Regulatory affairs of a Pharmaceutical or related field, with at least two (2) years in a senior position.
  • Knowledge of the Canadian and American Regulatory Guidelines and GMPs
  • Knowledge of Market Access
  • Excellent knowledge with preparation of e-CTD documents
  • Bilingualism, French and English (oral and writing)
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