Regulatory CMC Consultant

Genepool Networks; Massachusetts; Remote; USD 138,000 - 207,000; Full time

Job summary

Genepool Networks is seeking an experienced Regulatory CMC Consultant to support global late-stage biologics programs through key regulatory milestones, including BLA preparation and submission.

This role will serve as a critical partner to internal CMC and regulatory teams, providing expert guidance, hands‑on authoring, and strategic oversight across all phases of biologics manufacturing—from upstream and downstream process development to drug substance, drug product, and fill/finish

Qualifications

• 10+ years of Regulatory CMC experience in biotech/biopharma with biologics.
• Proven experience authoring and reviewing BLA submissions and global filings.
• Deep knowledge of FDA, EMA, ICH guidance for late-stage programs.
• Strong written and verbal communication of complex CMC concepts.

Responsibilities

• Lead or contribute to CMC sections for INDs, BLAs and global submissions.
• Ensure alignment of manufacturing, quality, and regulatory strategies.
• Provide regulatory input on process changes, comparability, and post-approval changes.
• Collaborate with CMC, Quality, Analytical Development and Manufacturing teams.
• Interface with regulatory agencies as needed for queries and briefing packages.
• Advise on global regulatory strategies for U.S., EU, and other regions.

Skills

Regulatory CMC

Biologics experience

BLA submissions

Global regulatory knowledge

Education

Advanced degree in Biochemistry/Regulatory Science

Job description

This range is provided by Genepool Networks. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$100.00/hr - $150.00/hr

Direct message the job poster from Genepool Networks

Location: Remote (U.S.)

Engagement: Contract / Consulting

Duration: 6–12 months (with potential extension)

About the Role

We are seeking an experienced Regulatory CMC Consultant to support global late-stage biologics programs through key regulatory milestones, including BLA preparation and submission. This role will serve as a critical partner to our internal CMC and regulatory teams, providing expert guidance, hands‑on authoring, and strategic oversight across all phases of biologics manufacturing—from upstream and downstream process development to drug substance, drug product, and fill/finish operations.

This is an individual contributor role requiring a seasoned professional with deep technical and regulatory experience in biologics CMC for global Phase 3 and registration‑stage programs.

Responsibilities

Lead or contribute to the authoring and review of CMC sections for INDs, BLAs, and global regulatory submissions.

Ensure alignment between manufacturing, quality, and regulatory strategies for late-stage biologics development and commercialization.

Provide expert regulatory input on process and analytical changes, comparability assessments, and post‑approval change management strategies.

Collaborate cross‑functionally with CMC, Quality, Analytical Development and Manufacturing teams to ensure regulatory readiness and consistency of documentation.

Interface with regulatory agencies as needed to support CMC‑related queries, briefing packages, and meeting preparation.

Advise on CMC regulatory strategies for global filings (U.S., EU, and other major regions).

Maintain awareness of evolving global CMC guidance, trends, and expectations.

Qualifications

10+ years of relevant Regulatory CMC experience within the biotech or biopharma industry, with a focus on biologics.

Proven experience authoring and reviewing BLA submissions and related global regulatory filings.

Comprehensive understanding of CMC requirements across upstream, downstream, drug substance, drug product, and fill/finish.

Strong knowledge of global regulatory frameworks (FDA, EMA, ICH) for late‑stage and commercial biologics.

Exceptional attention to detail and ability to communicate complex CMC and regulatory concepts clearly.

Advanced degree in a scientific discipline (Biochemistry, Biotechnology, Regulatory Science, or related field) preferred.

Seniority level

• Director

Employment type

• Contract

Job function

• Science

Industries

• Biotechnology Research and Pharmaceutical Manufacturing