Introduction

Regulatory Consultant, Part-time (6-month contract)Remote - Canada

What are you going to do 

ResponsibilitiesGlobal Regulatory Strategy
* Support the development and execution of the global regulatory strategy for the assigned investigational drug. * Identify regulatory opportunities, risks and key strategic considerations throughout early clinical development.
* Provide regulatory recommendations to support clinical development plans and key program decisions. * Ensure alignment of regulatory strategy with the broader clinical and development objectives for the asset.
* Support planning for the program's transition from early development into the late-stage regulatory organization around Phase 1b/Phase 2. FDA and EMA Regulatory Leadership
* Provide strategic guidance regarding FDA and EMA regulatory requirements and expectations.* Support preparation for health authority meetings, scientific advice and other regulatory interactions.
* Contribute to briefing documents, regulatory questions, responses and meeting strategy. * Translate health authority feedback into clear recommendations and regulatory actions for the development team.
Early Clinical Development * Provide regulatory leadership for activities supporting Phase 1 through Phase 1b/Phase 2 development.
* Advise on regulatory considerations affecting clinical development plans, study design and development milestones. * Support IND and CTA activities, including ongoing regulatory maintenance and development-related submissions.
* Identify regulatory issues that could affect development timelines or future global submission strategy. Cross-Functional Leadership
* Partner closely with regulatory, clinical/medical, safety, CMC and other development functions as appropriate. * Participate in relevant cross-functional development team discussions.
* Ensure regulatory considerations are incorporated into key development decisions. * Build alignment across stakeholders while working within the direction and governance established by the client's Early Development Regulatory team.
Regulatory Deliverables and Execution * Lead or support preparation and review of key regulatory documents and deliverables.
* Ensure regulatory activities are consistent with the agreed global strategy. * Provide strategic review and regulatory input into development documentation.
* Support seamless knowledge transfer and regulatory transition as the asset progresses toward Phase 2.

Essential skills and knowledge

Requirements

  • Significant pharmaceutical/biotechnology drug development and global regulatory affairs experience.
  • Extensive experience developing and executing global regulatory strategies.
  • Strong, direct experience working with both the FDA and EMA.
  • Demonstrated experience supporting early-stage clinical development, ideally from Phase 1 through Phase 2.
  • Strong experience with IND and CTA development and maintenance.
  • Experience preparing for and participating in health authority meetings and scientific advice.
  • Experience developing regulatory strategy across multidisciplinary drug development teams.
  • Ability to identify strategic regulatory drivers, risks and opportunities during early development.
  • Demonstrated ability to operate independently in a senior advisory/consulting capacity while working within an established regulatory governance structure.
  • Experience transitioning programs from early development into later-stage development teams.
  • Engagement: Temporary consulting assignment
  • Commitment: Approximately 0.3-0.4 FTE
  • Start: As soon as possible
  • Expected End: Approximately mid-2027
  • Scope: One investigational asset
  • Development Window: Phase 1 through transition toward Phase 2

What we offer 

Important: This consultant will support the development and execution of the regulatory strategy but will not replace the client's internal strategic ownership. Accountability and oversight will remain with the client, with the consultant functioning as a senior extension of the Early Development Regulatory Strategy team.

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.

Closing: 31 January 2027

Apply Now

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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

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