Remote Senior CMC Regulatory Affairs Expert: Biologics

Parexel; Augusta (ME); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics to join remotely. You will support regulatory strategy and compliance for drug development across investigational, new, and marketed products for large biopharmaceutical partnerships, ensuring GMP compliance and successful submissions to FDA, EMA, and Health Canada.

You’ll collaborate with manufacturing, quality, and project management teams, develop CMC regulatory strategies, and contribute to product development from

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD)
• 7+ years of CMC experience in pharma with regulatory filings
• Experience with biologics and small molecules development and post-approval
• Preparing CMC sections for IND/NDA/DMF submissions for FDA and international agencies
• Global regulatory environment knowledge
• Strong analytical and negotiation skills
• Clear communication with manufacturing, quality, and regulatory teams
• Independent, multi-project prioritization in matrixed environments
• Proficiency with MS Office applications

Responsibilities

• Support regulatory leads in developing CMC regulatory strategies and contingency plans for biologic and small molecule drug substances, drug products, and drug-device combos
• Determine regulatory and scientific/technical requirements for CMC and GMP-related submissions
• Represent CMC regulatory affairs in project team meetings and provide regulatory guidance across functions
• Prepare, coordinate, and review all CMC and GMP documents for regulatory submissions
• Develop CMC regulatory strategies from development through marketing approvals
• Interact with manufacturing, quality, and partners to address CMC issues
• Maintain relationships with local and global functional units and external partners
• Support health authority CMC meetings and mock meetings
• Suggest ideas to optimize CMC regulatory processes
• Demonstrate proficiency with CREDO, ORIOM, Trackwise Digital, and TRS Viewer

Skills

Regulatory affairs

CMC

Strategic thinking

Analytical skills

Negotiation skills

Communication

Project management

Cross-functional collaboration

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD)

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

Tools

Trackwise Digital

CREDO

ORIOM

TRS Viewer

Microsoft Office (Word, Excel, PowerPoint, Outlook)

Job description

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics to join remotely. You will support regulatory strategy and compliance for drug development across investigational, new, and marketed products for large biopharmaceutical partnerships, ensuring GMP compliance and successful submissions to FDA, EMA, and Health Canada.

You’ll collaborate with manufacturing, quality, and project management teams, develop CMC regulatory strategies, and contribute to product development from