Regulatory Affairs Consultant - CMC Biologics / Plasma Products

Job overview

The Regulatory Affairs Consultant - CMC Biologics / Plasma Products role is remote, with the listing location in Hartford, CT. Compensation is not specified. Parexel provides clinical development and consulting solutions to the life sciences industry. The consultant supports post-approval regulatory activities by developing submission strategies, assessing quality changes, and coordinating accurate regulatory documentation. The work helps maintain compliance and support product approvals and market expansion across global markets.

What you'll do

• Develop post-approval CMC submission strategies and plans
• assess change controls and quality changes
• review manufacturing and quality documentation
• coordinate submissions with cross-functional teams
• write and review submission content
• maintain worldwide submission information in regulatory systems
• and identify, escalate, and mitigate regulatory risks.

What we're looking for

Skills & competencies

regulatory affairs consultant

cmc

biologics

plasma products

post-approval regulatory affairs

regulatory submissions

quality documentation

global markets

remote

parexel

regulatory information management

veeva vault preferred

life sciences

401(k) match

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) match
• and pet insurance.

Why this role

Requires a bachelor's degree in chemistry or a related life sciences field, five or more years of relevant regulatory experience, CMC submission-writing experience, and biologics regulatory CMC experience. Plasma product knowledge is a plus.

About the employer

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