Remote Senior Regulatory Affairs Lead, CMC Biologics

Parexel; Frankfort (KY); Remote; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics for a remote role. You will drive regulatory strategy, prepare CMC documentation, and ensure GMP/compliance across biologics and small molecules for global submissions.

You’ll collaborate with manufacturing, quality, and project management to support FDA, EMA, and Health Canada activities and help shape regulatory outcomes throughout development and post-approval.

Qualifications

• 7+ years of CMC experience with regulatory filing documentation
• Knowledge of drug development, GMP, and regulatory substrates (IND/NDA/DMF)
• Experience preparing CMC sections for FDA/EU/Canada submissions
• Strong analytical, organizational, and negotiation skills
• Ability to work in cross-functional, matrixed environments

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecules
• Prepare and review CMC and GMP documents for regulatory submissions
• Guide cross-functional teams with regulatory requirements and guidance
• Support health authority meetings and post-approval changes
• Collaborate with manufacturing and quality on CMC issues
• Maintain relationships with global regulatory units and external partners

Skills

Regulatory analysis

Strategic thinking

Problem-solving

Collaboration

Communication skills

Microsoft Office

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy

Master's degree or Ph.D. in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology

Tools

CREDO

ORIOM

Trackwise Digital

TRS Viewer

Job description

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics for a remote role. You will drive regulatory strategy, prepare CMC documentation, and ensure GMP/compliance across biologics and small molecules for global submissions.

You’ll collaborate with manufacturing, quality, and project management to support FDA, EMA, and Health Canada activities and help shape regulatory outcomes throughout development and post-approval.