Regulatory Affairs Manager

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

• 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).