Regulatory Affairs/ CMC Consultant
We are seeking an experienced Regulatory & CMC Lead to guide the chemistry, manufacturing, and controls strategy for a regulated cannabis inhalation product targeting medical and medically‑adjacent markets. This is a part‑time, long‑term contract role focused on building pharma‑grade documentation, specifications, and regulatory readiness appropriate for inhaled products, while remaining pragmatic to the realities of the cannabis landscape.
The ideal candidate will bring deep expertise in CMC strategy and regulatory expectations for inhalation or combination products, and will serve as a trusted advisor to R&D, formulation, device, and manufacturing teams. A prototype and development foundation are in place; the objective of this role is to proactively strengthen the product's regulatory posture, consistency, and lifecycle control.
Scope of Work
- Development of overall CMC strategy for an inhaled cannabis product, aligned with medical‑market expectations
- Definition and refinement of product specifications, including critical quality attributes and acceptance criteria
- Design and oversight of stability programs, including in‑device stability and shelf‑life justification
- Guidance on change control, comparability, and lifecycle management as the product evolves
- Advisory support on regulatory readiness for inhalation products, including documentation structure and data expectations
- Cross‑functional collaboration to align formulation, device, manufacturing, and quality considerations
Ideal Candidate Profile
- Extensive experience in Regulatory Affairs, CMC, or Quality for pharmaceutical, inhalation, or combination products
- Strong understanding of inhaled product requirements, stability science, and specification setting
- Experience preparing products for regulated or medical markets, even outside a traditional FDA pathway
- Ability to balance regulatory rigor with practical development and commercialization constraints
- Clear communicator who can translate regulatory expectations into actionable development guidance
Role Details
- Time commitment: 5-10 hours per week, ad hoc
- Term: Up to 2 years
- Location: Fully remote (United States)
- Compensation: Competitive; equity and/or profit‑share structures may be considered
- Engagement type: W2 only
FAQs
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