About the Role
We are constantly building a curated list of external regulatory affairs CMC consultants for on-demand client projects focused on small molecule, synthetic peptide, and/or oligonucleotide product development, from pre-IND through marketing application submissions. While some client projects may be in later phases, the main focus of the role will be supporting early-stage clinical development (pre-IND through phase 2).
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.
Requirements
Qualifications:
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.
Preference for individuals that have led the CMC aspects of a development program through clinical to marketing submission and can speak confidently to these experiences.
Also, preference for individuals with prior hands-on QC/R&D laboratory and/or manufacturing process development experience and can speak confidently to the phase-appropriate manufacturing and controls requirements.
Professional liability insurance
Ideal Experience Includes:
Phase-appropriate CMC module preparation (IND / IMPD / NDA / BLA)
Vendor selection and oversight for analytical methods/DP/DS
Familiarity with eCTD Module 3 authoring
Direct experience working with US FDA (meeting prep, RTQs, etc.)
Strategic problem-solving in early and late-phase development
Various dosage forms: tablets, capsules, sterile solutions, granules, etc.
Experience with traditional manufacturing processes and/or continuous manufacturing processes
Interested?
Please email your CV/Resume to cmc-consultant@nexus-cmc-advisors.odoo.com (Note: clicking the apply button or email address will open the email address in your preferred email program) . In the body of the email, provide any summary of why partnering with us appeals to you and why you think this would be a good fit. Also, in the body of the email, answer the following questions:
What is your level of proficiency in English? (Native, bilingual, professional)
Are you willing to undergo a background check, in accordance with local law/regulations? (Yes or No)
Are you legally authorized to work in the United States? (Yes or No)
Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)? (Yes or No)
How many years of experience do you have directly interacting with the FDA (eg, meetings and responses)?
Are you comfortable working independently with pharma/biotech clients to address their Reg CMC needs within your expertise? (Yes or No)
Are you comfortable independently authoring IND module 3 sections, briefing packages, and responses to questions/information requests? (Yes or No)
Do you have Professional Liability / Errors and Omissions Insurance or will you be obtaining insurance in the near future? (Yes or No)
What is your desired hourly rate (USD)?
Emailed resumes/CVs without answering the prerequisite questions above will not be considered. If you do not hear back from us within 6 months of the initial application submission, as we do not currently have the capacity to respond to all applications individually, either we do not have a client that fits your profile at this time or your application has been deemed as not a good fit for the type of work we perform. No sponsorship is offered for this contract position. Do not reach out to Nexus personnel outside of this posting.
We look forward to reviewing your application!
Let’s collaborate to bring more clarity and quality to the regulatory process.
About the Company
Nexus CMC Advisors specializes in regulatory affairs CMC and drug development, supporting pharmaceutical and biotechnology companies worldwide with US FDA submissions. We are seeking multiple experienced, director-level Regulatory Affairs CMC Consultants with a track record of success supporting small pharma or biotech clients with US submissions. This contract role offers the opportunity to shape regulatory strategies, lead interactions with health authorities, and contribute to the success of innovative drug products.