Regulatory Consultant, Part time (6-month contract) Remote
- Canada Introduction We are hiring for a Regulatory Consultant for one of our life sciences clients. This is a 6-month, part-time contract requiring up to 17 hours per week. The position is fully remote within Canada, with

working hours
coinciding with EU business hours. Our client is seeking an experienced Global Regulatory Lead (GRL) to provide strategic regulatory support for an antibody-based investigational therapy being developed for mild-to-moderate asthma, supporting the early-development asset as it progresses from Phase 1 toward Phase 2. The consultant will operate as an extension of the client's Early Development Regulatory Strategy team, working closely with regulatory leadership, medical and clinical colleagues, and other cross-functional stakeholders. The successful consultant will bring significant global drug development experience, particularly with the FDA and EMA, and will be comfortable providing both high-level regulatory strategy and hands-on support for key regulatory activities and deliverables while working independently and maintaining close alignment with the broader development team. Responsibilities Global 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.
- Strong cross-functional communication, influencing and stakeholder-management skills.
- Experience transitioning programs from early development into later-stage development teams. Highly Desirable Experience
- Experience with biologics and/or antibody-based therapeutics.
- Respiratory drug development experience, particularly asthma, would be advantageous.
- Experience working across both large pharmaceutical and emerging biotechnology environments.
- Experience supporting global development programs beyond the US and EU.
- Broader experience with NDA/MAA strategy, even though this particular assignment is focused on early development, would be valuable because the consultant should understand how early regulatory decisions can affect later development.
- Global Regulatory Strategy
- FDA and EMA Regulatory Strategy
- Early Clinical Development
- IND/CTA Development and Maintenance
- Health Authority Meetings & Scientific Advice
- Clinical Development Planning
- Regulatory Risk Assessment
- Cross-Functional Leadership and Influence
- Strategic Regulatory Decision-Making
- 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.

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📌 Regulatory Affairs Consultant (Canada)
🏢 Brunel
📍 Canada