Remote CMC Regulatory Strategist, Biologics

Parexel; Augusta (ME); Remote; USD 120,000 - 165,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity based. The role provides CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products to support US, EU, and Canada approvals.

You will prepare and review CMC/GMP documentation, collaborate with manufacturing, quality, and external partners, and contribute to global regulatory strategy from development through post-approval changes.

Qualifications

• Knowledge of drug development, GMP, and regulatory submission processes.
• Experience preparing CMC sections for IND/NDA/DMF filings.
• Ability to work in a regulated pharmaceutical environment with cross-functional teams.
• Strong written and verbal communication for regulatory documents.

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecules for development and post-approval changes.
• Prepare and review CMC and GMP documents for regulatory submissions to authorities.
• Represent CMC Regulatory Affairs in project teams and cross-functional meetings.
• Support health authority CMC meetings and monthly CMC GRT meetings.
• Collaborate with manufacturing, QA, affiliates, and external partners on CMC issues.
• Identify opportunities to optimize regulatory processes and timelines.

Skills

Strategic thinking

Analytical skills

Negotiation

Collaboration

Presentation skills

Multi-project mgmt

Regulatory submissions

Education

Bachelor's degree in Pharmaceutical Sciences or Chemistry, or a Pharm.D.

Master's or Ph.D. in Pharmaceutics/Biochemistry/Biology/Biotechnology

Tools

TrackWise Digital

TRS Viewer

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity based. The role provides CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products to support US, EU, and Canada approvals.

You will prepare and review CMC/GMP documentation, collaborate with manufacturing, quality, and external partners, and contribute to global regulatory strategy from development through post-approval changes.