Regulatory Affairs Senior Associate

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Location
Montreal
Job Type
Permanent position
Category
Pharmaceutical/Biotechnology
Job number
091580
Scolarship
BAC
Spoken and written languages
Français, English
Used softwares
Suite Office

Description

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).
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