Regulatory Affairs Manager

Envoyer cette publication à un ami Envoyer cette publication à un ami
This job posting expired and applications are no longer accepted.
This job posting was marked by employer as filled and is probably no longer available
Job Type
Permanent position
Job number
Spoken and written languages
Français, English
Used softwares
Suite Office


Our client, a growing specialty pharmaceutical company with infrastructures for R&D, manufacturing, distribution, and marketing. Their vast portfolio are distributed to retail pharmacies, hospitals and clinics. Their products are also exported to several countries.

The Regulatory Affairs Senior Associate is responsible to provide a full-range of regulatory support to the Senior Director of Regulatory Affairs and other internal teams, including submission preparation and document authoring.

Main responsibilities: 

  • Prepare and review submissions for different dosage forms to Health Canada and provincial formularies, including FDA submissions;
  • Compile submissions in CTD format as per Health Canada’s guidelines;
  • Prepare and review responses to the deficiency letters in a timely manner;
  • Assist in negotiations with Health Canada to ensure a prompt approval for the files in review, if needed;
  • Maintain current awareness of all regulatory guidelines (Health Canada, ICH, FDA and provincial);
  • Critical assessment of data and documents to identify gaps compared to regulatory requirements for US and Canada;
  • Working knowledge of Pharmacovigilance and associated duties


Specific knowledge

  • Minimum of 5 years hands-on experience in regulatory submission preparation;
  • Must have B. Sc. Degree in Pharmacology, Biochemistry and/or relevant disciplines
  • Able to manage multiple projects and tight timelines;
  • Problem resolution skills;
  • Bilingualism, French and English (oral and writing).

Related Jobs