Regulatory Affairs Project Manager

PUB326022

medical device pharmaceutical food industry

About this job

  • Industry: Pharmaceutical
  • Area of expertise: Regulatory
  • Location: Etobicoke

What is required?

  • Hours per week: 40
  • Education level: Academic Bachelor
  • Closing date: Saturday, 11 December 2021

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

Requirements

Requirements

  • 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

Benefits

Benefits

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We’ll get you going while you get on with the job.

About Brunel

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About Brunel

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.

Please share this job description with your network, we never know who is looking for new challenges.

For more information please reach out to Riham Hamdan at r.hamdan@brunel.net

Connecting Specialists to Pioneering Projects

How to apply

How to apply

If you meet the above requirements and would like to be considered for this role, please submit your interest using the ‘Apply’ button. Applying is quick and easy – just make sure you have the following documents ready to go:

  • Resume
  • Cover Letter (optional)
Apply now

Do you have questions?

If you have questions or would like to discuss the details of this role, please contact Riham Hamdan via the details below, quoting publication number:
PUB326022

Account manager

Riham Hamdan
Brunel Canada - Toronto
r.hamdan@brunel.net

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