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

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Do you have questions?

Vacancy reference: CR-277784

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Corporate recruiter

Alyssa DeRosario

+1 403 539 5009

Contact

Application process

First Contact

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.

Scheduling an Interview

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

Phone/ 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.

Meeting in Real Life

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.

Application for the Position

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