Remote CMC Regulatory Affairs Consultant, Biologics

Parexel; Atlanta (GA); Remote; USD 120,000 - 160,000; 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. You will provide CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products across US, EU, and Canada, supporting timely approvals.

In this fast-paced role, you will prepare CMC and GMP documentation, participate in health authority meetings, collaborate with manufacturing, quality, and external partners, and contribute to regulatory strategy

Qualifications

• Experience in the pharmaceutical industry within a regulated environment.
• 4–6 years of CMC experience with regulatory filing documentation.
• Knowledge of GMP, drug development, and global regulatory requirements.
• Experience preparing CMC sections for IND, NDA, DMF submissions.
• Ability to work in a matrixed, cross-functional team and lead meetings.
• Strong communication, organizational, and negotiation skills.

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecules.
• Coordinate and review CMC/GMP documents for regulatory submissions.
• Represent CMC Regulatory Affairs in project team meetings.
• Prepare for health authority CMC meetings and plan mock sessions.
• Support monthly CMC GRT meetings with global cross-functional teams.
• Build relationships with manufacturing, quality, and external partners.

Skills

Strategic thinking

Analytical problem solving

Negotiation

Collaborative communication

Presentation skills

Lead meetings

Education

Bachelor's degree in Pharmaceutical Sciences or Chemistry

Pharm.D.

Master's or Ph.D. preferred

Regulatory Affairs Certification (RAC)

Tools

Trackwise Digital

TRS Viewer

Microsoft Office (Word/Excel/PowerPoint)

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 across US, EU, and Canada, supporting timely approvals.

In this fast-paced role, you will prepare CMC and GMP documentation, participate in health authority meetings, collaborate with manufacturing, quality, and external partners, and contribute to regulatory strategy