Regulatory Affairs Project Leader

PUB283234

About this role

We’re hiring a Regulatory Affairs Project Leader for our client, a global pharmaceutical company, to join their team. This is a one-year contract opportunity that renews annually.

Responsibilities

  • File regulatory submissions) to Health Canada to maintain compliance for marketed products with a focus on product monographs and drug labels;
  • Update required internal systems and databases with regulatory affairs information, as per company SOPs;
  • Communicate and work with company’s local (e.g., Canada brand team) and global stakeholders, according to SOPs;
  • Prepare ASMF (Active Substance Master File) regulatory submissions to Health Canada;
  • Interact directly with Health Canada, and to address questions on filed submissions to ensure approval;
  • Review promotional and non-promotional material to ensure compliance for all products (marketed or development) from the company portfolios.

Requirements

Requirements

  • Bachelor’s Degree in Pharmacy or any health-related field;
  • 3+ years’ experience in preparation of regulatory submissions;
  • French and English (written and spoken);
  • Good understanding of the current Health Canada regulations and guidelines, especially clinical and labeling issues;
  • Good teamwork and ability to work independently;
  • Computer knowledge of Microsoft Office Suite; Adobe Acrobat;
  • Organized, attention to detail and deadline driven.

Benefits

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

Career interview session

Join the Brunel Family

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Application process

1

We carefully review your application and in the coming weeks, you will be notified for an interview session if you are selected. Only shortlisted candidates will be contacted within 7 days.

2

After being shortlisted, you will be contacted via email or telephone to arrange for a date on your availability for the qualification interview.

3

During the interview, you will be assessed on your level of experience and skills, work history, availability, and the qualifications the company is seeking for the position.

4

After successfully making through the phone interview, a face to face interview will be scheduled between the candidate and recruiter. This session can be a more in-depth interview to review your communication and interpersonal skills.

5

Submission of candidates resume for client’s approval and screening.

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
Apply now

Any questions remaining?

Your consultant, Maria Camanag is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB283234

Account manager

Maria Camanag
Brunel Canada - Toronto
m.camanag@brunel.net

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