Remote Senior Regulatory Affairs Consultant - CMC Biologics

Parexel; Columbus (OH); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

401(k) with Company match

Pet Insurance

Job summary

Parexel, a global clinical development partner, is seeking a Senior Regulatory Affairs Consultant – CMC Biologics to support regulatory strategy and compliance in a remote capacity. You will lead CMC regulatory activities for biologics and small molecules, coordinating with FDA, EMA, and Health Canada submissions while working across manufacturing, quality, and project teams.

This role offers growth in regulatory leadership, exposure to diverse biotech programs, and opportunities to deepen

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD).
• 7+ years of CMC experience in the pharmaceutical industry with a history of regulatory filings.
• Knowledge of drug development, GMP, and regulatory requirements for biologics and small molecules.
• Experience preparing CMC sections for IND/NDA/DMF submissions (FDA, EU, Canada).
• Strong analytical, negotiation, and communication skills.
• Proficiency with Office tools and regulatory information systems.

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecules across development to post-approval.
• Prepare and coordinate CMC and GMP documents for regulatory submissions.
• Provide guidance to cross-functional teams in global regulatory matters.
• Support health authority meetings and post-approval changes.
• Collaborate with manufacturing, quality, and external partners to resolve CMC issues.

Skills

Regulatory strategy

CMC regulatory

GMP knowledge

Cross-functional collaboration

Regulatory documentation

Regulatory information systems

Education

Bachelor's in Pharmaceutical Sciences/Chemistry/Pharmacy

PharmD (preferred)

Tools

CREDO

ORIOM

TrackWise Digital

TRS Viewer

Job description

Parexel, a global clinical development partner, is seeking a Senior Regulatory Affairs Consultant – CMC Biologics to support regulatory strategy and compliance in a remote capacity. You will lead CMC regulatory activities for biologics and small molecules, coordinating with FDA, EMA, and Health Canada submissions while working across manufacturing, quality, and project teams.

This role offers growth in regulatory leadership, exposure to diverse biotech programs, and opportunities to deepen