Regulatory Affairs Consultant — CMC Biologics

Job overview

The Regulatory Affairs Consultant, CMC – Biologics role is described as remote, with US, EU, and Canada regulatory responsibilities. The listing does not specify numeric compensation; it describes salaries as competitive and based on several factors. The role supports Parexel’s clinical development and consulting work for the life sciences industry. The consultant contributes CMC regulatory expertise to help investigational, new, and marketed products meet global requirements and progress through approvals and lifecycle changes. The role supports regulatory strategy, prepares and reviews submission materials, and coordinates with regulatory leads and cross-functional partners.

What you'll do

• Support CMC regulatory strategies and contingency plans for biologic and small-molecule products and drug-device combinations
• determine requirements for CMC and GMP submissions
• prepare, coordinate, and review submission documents
• support project-team representation and health-authority meeting preparation
• participate in global CMC meetings
• collaborate with manufacturing, quality, technical operations, affiliates, and external partners
• prepare departmental procedures and identify process improvements.

What we're looking for

Skills & competencies

regulatory affairs

cmc

biologics

small molecules

gmp documentation

regulatory submissions

health authority meetings

drug development

parexel

remote

Work arrangement

• Weekend coverage required

Benefits & perks

• Health, vision, and dental insurance
• tuition reimbursement
• vacation, holiday, and sick time
• flexible spending and health savings accounts
• 401(k) with company match
• pet insurance.

Why this role

CMC regulatory work spans development through post-approval changes, with primary regulatory responsibility for the US, EU, and Canada.

About the employer

Parexel is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.