Introduction

CMC Regulatory Consultant (6-month contract, 10 hours per week)

Hamilton, ON

What are you going to do 

Responsibilities

  • Serve as the CMC regulatory point of contact for global Health Authority Questions (e.g. FDA, EMA, MHRA, PDMA, other regions as applicable).
  • Train on the company's ERV/Veeva Vault system and manage HAQ responses within the ERV system
  • Coordinate HAQ response development across internal technical teams.
  • Track HAQs, response timelines, commitments, and dependencies to ensure on-time, high-quality submissions.
  • Interpret and apply global/regional CMC regulatory guidelines and regulations.
  • Review SME-drafted HAQ responses for regulatory appropriateness, clarity, consistency and alignment with regional CMC expectations.
  • Extract and summarize scientific information from development reports and identify details required for regulatory submissions.
  • Organize data to support the group's function with answering questions, information request from regulatory agencies such as the FDA, Health Canada or EMEA (including relevant country specific authorities).
  • Advise SMEs on how to frame technical data and rationales to meet Health Authority expectations.

Essential skills and knowledge

Requirements

  • Advanced degree in a scientific discipline (e.g. Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology,) or equivalent experience.
  • 8+ years of experience in CMC Regulatory Affairs in the pharmaceutical and/or biotechnology industry.
  • Prior radiopharmaceuticals experience is preferred.
  • Experience with ERV (RIM) systems is preferred.
  • Excellent regulatory writing and editorial skills.
  • Hands-on experience managing and responding to global Health Authority Questions (HAQs).
  • Strong understanding of CMC requirements for early and late phase development (IND/CTA, BLA/NDA/MAA).
  • Extensive knowledge of eCTD structure and subsections, including appendices.
  • Knowledge of product lifecycle - Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing.
  • Excels at working in a collaborative environment as a member of a multidisciplinary team.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
  • Must have good time management skills, capable of timely delivery of CMC sections.
  • Must be flexible and able to handle changing priorities.
  • Ability to operate with an integrated view of CMC strategy risks/benefits and company needs.

What we offer 

What We Offer

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 Us

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.

#BRUCAD

Closing: 03 May 2026

Apply Now

Are you the perfect match for this vacancy? Apply in 5 minutes and let's get in touch!

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Process of your application

Application process & contact

We will now begin examining your application: We will take a close look at your application documents and ask you for additional information if necessary. If your qualifications match our requirements, we will invite you to meet us for the first time.

Project discussion with our customer

If the introductory meeting goes well for you and us, we will arrange a meeting with the customer who has the perfect project for you. This gives you the opportunity to find out more about the customer and the project.

The decision

If you enjoyed the project discussion and the customer is also convinced of your expertise, we will ask you the final and decisive question: Do you want to get started at Brunel?

Introductory conversation with Brunel

In an introductory meeting, we would like to find out more about your interests, ambitions and professional developments. At the same time, we report on working at Brunel and provide information about all career opportunities and prospects.

Welcome to Brunel

Now great times are beginning! With Brunel you have countless opportunities to help shape technological progress. You decide how your career path goes. We support you in every phase of your career. You always have security behind you: Brunel!