Posted 5 days ago
Regulatory Consultant
@ Brunel
Canada
Overview
Brunel is hiring a part-time remote Regulatory Consultant on a 6-month contract in Canada. The role supports the global regulatory strategy for one investigational drug, covering FDA and EMA guidance, IND and CTA work, and health authority interactions through Phase 1 to Phase 2. Commitment is about 0.3-0.4 FTE, starting as soon as possible and ending around mid-2027.
Pay:
$160–$175 an hour
Responsibilities:
- Support the global regulatory strategy for an investigational drug
- Advise on FDA and EMA requirements and expectations
- Prepare for health authority meetings and scientific advice
- Support IND and CTA development and maintenance
- Support the transition from early development toward Phase 2
Requirements summary:
- Significant pharmaceutical or biotechnology regulatory affairs experience
- Direct experience with both FDA and EMA
- Strong IND and CTA experience
- Experience with early-stage clinical development, Phase 1 to Phase 2
- Experience operating as a senior advisor within governance structures
Source and dates
Employer career site / ATS feed · careerpage
- Employer posting date
- 2026-11-02
- First seen by our source
- 2026-11-02
- Source record updated
- 2026-11-02
These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.
Job details
| Seniority | Senior |
| Department | Business operations |
| Work setting | Home |
| Position | Mostly sitting |
| Physical demands | physical low · computer high |
| Languages | English |
Summary and details written by AI from the posting; the employer’s posting is the authority.
Brunel
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This is who we are: A powerful global network. Brunel – Connecting Specialists to Pioneering Projects.
Full company description
Founded in 1975, we are a global specialist delivering customised project and workforce solutions to drive sustainable industry transformations through technology and talent. With 120+ offices and a powerful network of more than 12,000 specialists around the world, we deliver Project and Consulting Solutions, Workforce Solutions and Global Mobility Solutions that transform global projects in Renewables, Conventional Energy, Mining, Life Sciences, Future Mobility, Industrials & Technology and many other sectors.
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Founded in 1975, we are a global specialist delivering customised project and workforce solutions to drive sustainable industry transformations through technology and talent. With 120+ offices and a powerful network of more than 12,000 specialists around the world, we deliver Project and Consulting Solutions, Workforce Solutions and Global Mobility Solutions that transform global projects in Renewables…
| Field | Value |
|---|---|
| Industry | Staffing and Recruiting |
| Company size | 10,001+ employees |
| Headquarters | Amsterdam |
| Organization type | Public Company |
| Year founded | 1975 |
| Specialties | RecruitmentStaffingTraineeshipsGlobal CompanyAutomotiveLegalFinanceMarketing & CommunicationHigh-techProject management |
| Open jobs on Jobsy | 80 |
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Regulatory Consultant, Part-time (6-month contract)Remote - Canada
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.
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
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.
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