Independent CMC Regulatory Affairs Consultant

A CMC regulatory affairs professional who turns technical data into an approval

Twenty-four years in CMC regulatory affairs across US and EU health authorities — writing, reviewing, and owning ANDAs, NDAs, and post-approval submissions end-to-end, not handing them between specialists.

Start a conversation See what I do

30+ yrs in the pharmaceutical industry 24 yrs CMC regulatory affairs (US & EU) 2 first-cycle ANDA approvals New Zealand time zone — a head start, not a gap RAC‑US · 2019, 99th percentile

Suzett L. Perry RAC‑US, Director

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Meet Suzett

“I take a company's source documents and reports and tell the story to regulators.”

Most CMC consultants come from one of two directions: a regulatory strategist who directs writing but does not write, or a medical/regulatory writer who drafts to spec but does not own regulatory strategy or agency interaction. My career runs the full pipeline — so a submission moves from source lab data to a first-cycle-approved dossier without being handed between specialists.

Suzett at Duder Regional Park, Auckland — Auckland, New Zealand

Bench scienceBiochemistry & pharmacokinetics lab work

Scientific writingEditing hundreds of FDA submission documents

Regulatory affairs24 years leading & owning CMC submissions

ApprovalFirst-cycle outcomes, no hand-offs

That technical ownership sits alongside years of remote leadership and hands-on collaboration with CMOs and clients — primarily in the US, with substantial work across the EU and some engagements in Australia. I have regularly provided practical solutions and strategic regulatory leadership to commercial, manufacturing, and quality teams, helping them meet regulatory standards while still meeting the business's commercial needs.

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What I do

Many CEOs, CMOs, and small pharma leaders think of regulatory affairs as a compliance cost center. My experience runs against that assumption — a strong CMC regulatory lead is a project driver and growth accelerator.

Narrative

Regulatory storytelling

Turning source documents and lab data into a clear, defensible regulatory narrative — using ICH and agency guidelines as the framework, not just formatting to spec.

Ownership

End-to-end submissions

ANDAs, 505(b)(2) NDAs, Generic MAAs (EU), deficiency responses, and the full post-approval lifecycle — with a track record including first-cycle ANDA approvals.

Compliance

High-friction compliance

Extractables & leachables, ICH Q3D elemental impurities, and drug-device threshold analysis — led from strategy through cross-functional execution.

Templates & process infrastructure Technical/lab document review Biosimilar & emerging modalities Remote, cross-timezone delivery Flexible, fractional engagement

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Credentials & coverage

Experience24 years in regulatory affairs, of 30+ total in the pharmaceutical industry

CitizenshipDual — US and New Zealand, no work-authorization friction

EducationB.S., Biochemistry (Indiana University); M.A. program, Statistics (Columbia University)

CertificationRAC‑US, RAPS (2019, 99th percentile score)

Covered by professional (errors & omissions) indemnity insurance, with coverage extending to US‑based engagements — a certificate is available upon engagement. Contract work is engaged through my company, Kinetic CMC Consulting Ltd.

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Who this is for

Regulatory consulting firms

Needing subcontract CMC writing and review capacity they can deploy against client work without ramp-up time.

Small-to-mid pharma & generics companies

Too small for a full-time Regulatory Affairs Manager, but needing senior CMC regulatory writing and review leadership on a fractional basis, at ANDA/NDA-caliber quality.

Companies facing a specific compliance project

Extractables & leachables, elemental impurities, drug-device threshold analysis, or early biosimilar development — where the value is hands-on leadership already gained on exactly this kind of project.

Pharmaceutical staffing agencies & recruiters

Looking for a CMC regulatory writer to place on a contract role — already carrying her own liability coverage and US-ready contracting entity, so there's no employment friction on your end.

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Questions I get asked

What does a CMC regulatory affairs consultant do?

Writes, reviews, and manages the technical documentation that supports a drug product's approval and post-approval lifecycle with health authorities like the FDA.

Do you prepare ANDAs and NDAs?

Yes — 24 years of experience preparing ANDAs, 505(b)(2) NDAs, Generic MAAs for the EU, and full post-approval submissions, including first-cycle ANDA approvals.

Can you support extractables & leachables or elemental impurities projects?

Yes. I've led a multi-site extractables & leachables project team and served as an award-winning regulatory lead on ICH Q3D elemental impurities.

Do you have biosimilar or biologic experience?

I served as regulatory lead on a biosimilar project team through an FDA Biosimilar Initial Advisory (BIA) meeting package — a working foundation, scoped honestly against each client's need.

How does contracting work for US clients?

Through my company, Kinetic CMC Consulting Ltd — US clients sign with Kinetic, request a W‑8BEN‑E rather than a W‑9, and pay in USD to a Kinetic‑held US bank account (Wise Business).

What engagement models are available?

Flexible arrangements from a few hours a week to full-time support, and from short-term projects to longer engagements.

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Let's talk

Open to a range of contracting arrangements — from a few hours a week to full-time support, short-term to long-term. Tell me a little about the work and I'll get back to you directly.

Direct

suzett.perry@gmail.com