Regulatory Affairs Specialist (CMC)

Montreal - Quebec - Canada - Life Sciences & Health Care - Pharmaceutical - Regulatory - Academic Bachelor

We’re hiring a Regulatory Affairs Specialist (CMC) for our client, a leading pharmaceutical company, to join their team. This is a permanent position.

Feel free to contact

Maria Camanag, Account manager

Apply now

About this role

Responsibilities

  • Manages the preparation of high quality regulatory submissions, including evaluation of data, regulatory strategy and project coordination according to predefined timelines;
  • Assumes responsibility for the maintenance and regulatory compliance for approved products for prescription and OTC drugs, natural health products and biologics, as well as medical devices;
  • Ensures that scientific data supporting variations, as well as daily regulatory activities, are in compliance with all relevant regulations guidelines and policies for the impacted territories;
  • Reviews and approves product labels to ensure compliance.

About you

Requirements

  • Bachelor Degree in Science or related field is required; Master Degree or better in Regulatory Affairs or related field preferred;
  • 2+ years of experience in the regulatory field within the pharmaceutical industry with a focus on CMC documentation;
  • Scientific knowledge;
  • Understanding of ICH guidelines, CTD requirements and pharmacopoeias;
  • Knowledge of the US and Canadian regulations and ability to interpret policies and guidelines;
  • Excellent communication skills across different audiences in English (essential) and French;
  • Good analytical skills with high-level attention to detail and commitment to accuracy and depth;
  • Adaptability in situations involving changes as well as the capacity to take action without having all the information. She/he will be able to handle multiple projects at a time;
  • Ability to work independently, yet interact with various departments and people as needed. She/he must demonstrate the ability to determine, initiate and complete tasks;
  • Good interpersonal skills that will allow him/her to effectively function in a fast-paced, people oriented, team environment;
  • Demonstrated proficiency in using Microsoft suite (including Word, Excel and PowerPoint) and Adobe.

What we offer

Why apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you, from submitting your resume, to coordinating interviews, to extending offers, and assisting with on-boarding. Let us get you going so you can get on with the job.

About us

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.

Summary

  • Vacancy number: PUB249852
  • Location: Montreal
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branch: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of Expertise: Regulatory
  • Closing date: Saturday, March 7, 2020
Apply now

Feel free to contact

MC

Maria Camanag

Account manager Brunel Canada Toronto

+1 416 244 2402

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