Regulatory Affairs Project Manager

PUB298020

About this role

  • We’re hiring Regulatory Affairs Project Manager for our client to join their team. This is a permanent 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.

Responsibilities

  • 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 Your strengths include;
  • 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

  • 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.
Asian colleagues having market discussion

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.

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, Monnatha Grego is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB298020

Account manager

Monnatha Grego
Brunel Canada - Calgary
m.grego@brunel.net

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