Connecting with Independent Regulatory Affairs CMC Consultants (1099, Project-Based)

Company Overview: Nexus CMC Advisors provides regulatory CMC strategy to emerging and lean pharmaceutical sponsors, with a focus on U.S. FDA submissions from pre-IND through Phase 2 (occasional later-phase work). We specialize in small-molecule, synthetic-peptide, and synthetic oligonucleotide therapeutics. We are expanding our curated bench of senior independent CMC consultants to support on-demand client engagements. We specialize in strategic CMC guidance for lean or emerging pharmaceutical companies—so we’re looking for consultants who thrive in ambiguous environments, communicate clearly, and deliver top-tier regulatory insights.

About This Role: This is a 1099 independent contractor engagement, not a W-2 position. Consultants on the Nexus bench are engaged project-by-project under an Independent Consultant Agreement, with individual Project Fee Addenda defining scope, deliverables, and fees. Work is performed remotely through your own business entity. We are looking for consultants who can independently own a CMC workstream end-to-end — strategy, authoring, CRO/CDMO oversight, and direct sponsor interaction — without senior Nexus review of day-to-day execution.

Education: Minimum of a Master’s degree in a scientific discipline (Ph.D. preferred).

Experience: At least 10 years (with a Ph.D.) or 12 years (with a Master’s) of hands-on experience in CMC regulatory affairs, with a focus on small molecules, peptides and/or oligonucleotides. Demonstrated ability to lead — not contribute to — CMC workstreams independently Authorship or substantial contribution to at least two INDsDirect U.S. FDA interaction experience (pre-IND, Type B, Type C meetings, responses to Information Requests) Fluent written English suitable for client-facing regulatory deliverablesU.S. work authorization (no sponsorship offered)

Qualifications: Preferred:

• Prior hands-on QC/R&D or manufacturing process development experience
• Familiarity with eCTD Module 3 authoring
• Experience with traditional and/or continuous manufacturing processes
• Program experience through NDA submission
• Engagement Terms — Please Review Before Applying
• By applying, you confirm willingness to work under the following terms if selected:
• Sign the Nexus Independent Consultant Agreement (Virginia governing law)
• Represent yourself as part of the Nexus team using a Nexus-branded email address during client engagements
• Perform all client work exclusively within the Nexus SharePoint environment (no downloads, syncing, or transfer of client files to personal devices or accounts)
• Carry Professional Liability / E&O insurance of at least $1,000,000 per claim
• Accept a 12-month post-engagement non-solicitation and non-circumvention obligation on Nexus clients
• Assign all work product and intellectual property to Nexus upon payment
• Standard hourly rate expectation in the $100–$200/hr range, or fixed project fees; final rate agreed per engagement
• Who This Is Not For:
• W-2 job seekers or those seeking full-time employment
• Junior consultants or those requiring senior oversight to complete deliverables
• Agencies or firms seeking to sub-contract
• Consultants focused on biologics, cell/gene therapy, or oligonucleotides
• Consultants unwilling to work exclusively within a client’s document environment

How to Apply: Applying to the Nexus consultant bench is a two-step process:1. Complete the Nexus Consultant Qualification Questionnaire (copy link to new browser window): https://forms.gle/rYQhPmT7U3Pwetiw72. Send your current CV to the email provided within the Questionnaire Both steps are required for your application to be reviewed (i.e., submitting through LinkedIn apply is not the application). If you carry Professional Liability / E&O insurance, please also attach a current Certificate of Insurance (COI) to the same email. Do not send inquiries through LinkedIn messages or to Nexus personnel directly — those will not be reviewed. We review completed submissions on a rolling basis. If your profile matches an upcoming engagement, we will contact you within 60 days. If you do not hear from us within 60 days, we do not currently have a client fit — we retain qualified submissions for future opportunities and may reach out later.