Regulatory Affairs Specialist

Career Connections Canada Inc.; Montreal; On-site; CAD 55,000 - 60,000; Full time

Job summary

A pharmaceutical company in Montreal is seeking a detail-oriented Talent Acquisition Specialist to lead regulatory projects and ensure compliance in the pharmaceutical industry. The ideal candidate holds a bachelor’s degree in Chemistry, Pharmacy, or Life Sciences and has over 5 years of experience in regulatory affairs. This role includes benefits such as dental care and paid time off, with a competitive salary range starting at CA$55,000.

Benefits

Dental care

Extended health care

Paid time off

Qualifications

• 5+ years of experience in pharmaceutical regulatory affairs, including Canadian submissions.
• Direct Manufacturing Pharmaceutical Experience is a MUST.
• Strong understanding of Canadian and US regulatory frameworks.

Responsibilities

• Lead and manage regulatory projects independently or with support.
• Prepare and submit dossiers to Health Canada and the US FDA.
• Build strong relationships with regulatory agencies.

Skills

Regulatory compliance expertise

Communication skills

Analytical skills

Education

Bachelor’s degree in Chemistry, Pharmacy, or Life Sciences

Tools

eCTD submission software

MS Office

Adobe Acrobat

Job description

Overview

Overview Talent Acquisition Specialist | Head Hunter | HRPA Certified | Working towards CHRP

Are you a detail-oriented professional with a passion for regulatory compliance in the pharmaceutical industry? Join our team and help shape the future of healthcare!

What You’ll Do

• Lead and manage regulatory projects independently or with support from internal / external teams.
• Prepare and submit dossiers to Health Canada and the US FDA, ensuring accuracy and compliance.
• Build strong relationships with regulatory agencies to stay ahead of evolving expectations.
• Respond to technical queries and deficiency letters in a timely manner.
• Mentor junior staff and collaborate cross-functionally.
• Monitor regulatory changes and maintain compliance for approved products.
• Review product labeling and promotional materials for regulatory alignment.

What You Bring

• Bachelor’s degree in Chemistry, Pharmacy, or Life Sciences (required).
• 5+ years of experience in pharmaceutical regulatory affairs, including Canadian submissions. Direct Manufacturing Pharmaceutical Experience is a MUST
• Strong understanding of Canadian and US regulatory frameworks (Health Canada, FDA, ICH).
• Proficiency in eCTD submission software, MS Office, and Adobe Acrobat.
• Excellent communication and analytical skills.

Benefits

• Dental care
• Extended health care
• Paid time off

Job Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Public Relations
• Industries: Pharmaceutical Manufacturing

Location Montreal, Quebec, Canada. Salary ranges listed include CA$55,000–CA$60,000 and CA$70,000–CA$80,000.