Remote CMC Regulatory Affairs Consultant - Biologics

Parexel; Boise (ID); Remote; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team remotely. You will provide CMC regulatory strategy for biologics and small molecule drugs, ensuring global regulatory compliance for FDA, EU, and Canada across development through post-approval changes.

You will collaborate with cross-functional teams, prepare CMC/GMP documents, and support health authority interactions. Prior regulatory submissions experience and strong communication skills are essential.

Qualifications

• Bachelor's degree or Pharm.D. required with 4–6 years CMC experience.
• Knowledge of GMP, drug development and regulatory submissions (IND/NDA/DMF).
• Experience preparing CMC sections for regulatory submissions (FDA/EU/Canada).
• Strong communication, negotiation, and analytical skills.

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecules.
• Prepare and review CMC and GMP submission documents.
• Represent CMC in cross-functional project teams and meetings.
• Support health authority meetings and regulatory strategy discussions.
• Collaborate with manufacturing, quality, and external partners to ensure compliant submissions.

Skills

Strategic thinking

Analytical problem solving

Negotiation

Collaboration

Regulatory knowledge

Project prioritization

Microsoft Office

TrackWise Digital

TRS Viewer

Education

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

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

Tools

TrackWise Digital

TRS Viewer

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team remotely. You will provide CMC regulatory strategy for biologics and small molecule drugs, ensuring global regulatory compliance for FDA, EU, and Canada across development through post-approval changes.

You will collaborate with cross-functional teams, prepare CMC/GMP documents, and support health authority interactions. Prior regulatory submissions experience and strong communication skills are essential.