Regulatory Affairs Project Manager

PUB275695

About this role

We’re hiring a Regulatory Affairs Project Manager for our client, a leading Pharmaceutical company. Reporting to the Director, Regulatory Affairs, The Associate Project Manager, Regulatory Affairs, will assume responsibilities within the Scientific Affairs department to ensure the timely approval and regulatory maintenance of pharmaceutical products in Canada, in collaboration with corporate partners. The ideal candidate is highly organized, has flexible and adaptable communications capabilities and demonstrates good problem-solving skills.

Responsibilities• Prepares quality regulatory submissions according to Health Canada standards and predefined timelines for drugs, biologics and natural health products. This includes:
Evaluating the available data (chemistry/ manufacturing, clinical and pre-clinical);Preparation of CTD summaries, including Module 1, according to Canadian requirements;
Preparation of responses to clarification requests according to the agency’s deadlines.• Liaise efficiently with internal and corporate partners for the preparation of regulatory dossiers, as well as during Health Canada review of the dossiers.
• In collaboration with Knight’s Quality Assurance, evaluates post-marketing changes to pharmaceuticalproducts.
• Participate to the review of the product’s labelling to ensure regulatory compliance.• Participate in the maintenance of the established documentation process and product history database within the Scientific Affairs department.
• If required, the candidate may also be requested to provide support to corporate partners for thepreparation of foreign regulatory dossiers according the guidance’s and policies in place within the targeted market.

Requirements

Requirements
• B.Sc. in life science discipline or equivalent• Minimum of 3 years in Canadian Regulatory Affairs in a pharmaceutical company
• Good scientific knowledge• Excellent communication skills; written and oral English and French
• Strong knowledge of Microsoft Office Suite• DESS or M.Sc. in drug development/regulatory affairs
• Good knowledge of drug development and/or manufacturing process• Previous CTA experience
• Previous NDS experience• Previous biologics experience

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.


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.

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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, Sinead McLaughlin is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB275695

Account manager

Sinead McLaughlin
Brunel Canada - Calgary
s.mclaughlin@brunel.net

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