Remote Senior CMC Regulatory Affairs Consultant (Biologics)

Parexel; Pierre (SD); Remote; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Vacation time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics to join our team in a remote capacity. You will support regulatory strategy and compliance for drug development, collaborating with manufacturing, quality, and project management to ensure global regulatory alignment.

The role involves preparing regulatory submissions, developing CMC strategies for developmental and marketed products, and working with Health Authorities worldwide to ensure compliance and timely market

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD).
• 7+ years of CMC experience with regulatory filing history.
• Know-how of drug development, GMP, and regulatory requirements globally.
• Experience preparing CMC sections (IND, NDA, DMF) for FDA/EU/Canada.

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecules.
• Prepare and review CMC and GMP documents for regulatory submissions.
• Provide regulatory guidance to cross-functional teams with global leads.
• Support health authority meetings and post-approval changes.

Skills

Strategic regulatory analysis

Regulatory filings (IND/NDA/DMF)

GMP knowledge

MS Office proficiency

Education

Bachelor's in Pharmaceutical Sciences/ Chemistry/ Pharmacy (PharmD)

Tools

CREDO

ORIOM

Trackwise Digital

TRS Viewer

Job description

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics to join our team in a remote capacity. You will support regulatory strategy and compliance for drug development, collaborating with manufacturing, quality, and project management to ensure global regulatory alignment.

The role involves preparing regulatory submissions, developing CMC strategies for developmental and marketed products, and working with Health Authorities worldwide to ensure compliance and timely market