Regulatory Affairs Project Manager


About this role: Regulatory Affairs Project Manager

About this role: Regulatory Affairs Project Manager

We’re hiring Regulatory Affairs Project Manager for our client to join their team. This is a contract position, requiring on-site presence a few days a week after Covid-19.

As the Regulatory Affairs Project Manager, you provide regulatory input and direction to the Canadian Cross Functional Team and Global regulatory teams to build regulatory strategies, deliver optimal Health Canada approvals (time and quality), maintain compliance and positively impact a product's potential and lifecycle in the Canadian marketplace. You actively support the team to maximize efficiency, performance and productivity.

  • Build and implement regulatory strategic plans including Regulatory Strategy Documents
  • Prepare, submit and negotiate of approvals of NDSs and SNDSs
  • Maintain regulatory compliance of approved products
  • Plan and conduct Health Canada meetings to ensure positive outcomes; work with external experts and participate in key external advisory boards
  • Build and release Health Professional and Public Communications
  • Review and approve promotional materials including artwork
  • Compile responses to ATI requests
  • Provide strategic and informed regulatory/business expertise across the organization as required
  • Influence the global development of products, representing the Canadian market, to mitigate regulatory risks in the development plans
  • Lead or participate in cross-functional and external initiatives
  • Ensure regulatory submissions and documents are aligned with both HPFB and company requirements and standards (e.g., Electronic submission processes)
  • Provide comments on emerging Canadian regulations/policies/guidelines/initiatives/surveys
  • Provide expertise and support to junior staff members (associates, students and assistants) to positively encourage development and knowledge transfer



  • B.Sc. or equivalent in a related (health science) discipline; advanced degree (M.Sc. or Ph.D.) is an asset
  • Strong knowledge of the Canadian regulatory environment and Health Canada regulations, policies and guidelines
  • Knowledge in one or more of the following key therapeutic areas CV-Metabolism, Oncology, and Respiratory/Immunology is ideal
  • Minimum 3-5 years regulatory experience in the brand name pharmaceutical or biotechnology industries
  • Minimum 2 years regulatory project management experience
  • Proficient in the use of MS Office
  • Superior negotiation skills, problem solving ability and innovative creative thinking
  • Excellent time management and organizational skills (able to manage multiple projects and priorities effectively)
  • Keen detail orientation to identify errors
  • Strong written and verbal presentation skills and adept at crafting business proposals and project plans
  • Ability to identify risk and build a plan to mitigate the risk
  • Positive interpersonal and relationship building skills with the ability to work effectively in a team both internally and externally



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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 45 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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For more information please reach out to Riham Hamdan at

Application process

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.

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

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.

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.

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

Start applying immediately

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, Riham Hamdan is happy to clarify anything about this vacancy. When reaching out, use the pub number:

Account manager

Riham Hamdan
Brunel Canada - Toronto

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