Remote CMC Regulatory Affairs Consultant – Biologics

Parexel; Carson City (NV); Remote; USD 100,000 - 150,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

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. You will provide CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products, focusing on US, EU, and Canada to support timely approvals.

You will work with global teams to prepare CMC/GMP submissions, support health authority meetings, and drive regulatory strategy from development through post-approval changes, enabling safe, high-quality

Qualifications

• Bachelor's degree in Pharmaceutical Sciences or Chemistry, or Pharm.D.
• 4-6 years of CMC experience in the pharmaceutical industry, with a history of regulatory filing documentation
• Knowledge of drug development, GMP, and regulatory requirements for biologics and small molecules
• Experience preparing CMC (Quality) sections for IND/NDA/DMF submissions and related regulatory activities
• Global regulatory awareness and proficiency with common regulatory tools and MS Office

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecule products.
• Prepare and review CMC and GMP documentation for regulatory submissions.
• Interact with cross-functional teams and lead regulatory discussions.
• Support health authority CMC meetings and monthly CMC GRT meetings.
• Represent CMC Regulatory Affairs in project teams and provide guidance.

Skills

Strategic thinking

Analytical problem solving

Negotiation

Team collaboration

Regulatory documentation

MS Office

Education

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

Tools

TrackWise Digital

TRS Viewer

NextGen portals

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics, to join our team in a remote capacity. You will provide CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products, focusing on US, EU, and Canada to support timely approvals.

You will work with global teams to prepare CMC/GMP submissions, support health authority meetings, and drive regulatory strategy from development through post-approval changes, enabling safe, high-quality