Regulatory Consultant
Canada
Parttime: 17 hrs a week / CA$ 160 - 175 per hour
Experience: 6-9 Years
Pharmaceuticals
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 knowledgeÂ
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.
Anything else ?
Shape your future
Are you ready for the next step in your career? Join Brunel’s powerful global network, where passionate, results-driven specialists come together with industry-leading clients. By connecting specialists to pioneering projects, we drive change in many industries, enabling growth and delivering great outcomes. Brunel helps you reach your full potential and empowers you to make an impact within a purpose-driven global company.
Explore your career opportunities!
Explore your career opportunities!
Our Culture and Values
At Brunel, we are proud of our unique corporate culture, which is shaped and nurtured by the collective efforts of our employees. Our work environment is characterised by an authentic, communicative and inclusive approach to teamwork that fosters an atmosphere of collaboration and creativity. Our values are at the center of everything we do – for our clients, our colleagues and ourselves.
Learn more about our global network of specialists!
Learn more about our global network of specialists!
Our ESG Commitment
Since 1975, our mission has always been to connect specialists to exciting career opportunities, to support the development of these careers, and to offer fair and equal employment. This has enabled us to create a truly sustainable and durable business model. Having a passion for people and caring deeply for the environment is not only part of Brunel’s DNA but is also reflected in our culture and values. As a global company, we take our social responsibility very seriously.
Join us on our mission!
Join us on our mission!
Are you the perfect match for this vacancy? Apply in 1 minute and let's get in touch!
