Senior Regulatory Affairs Consultant — CMC Post-Approval Vaccines

Job overview

The Senior Regulatory Affairs Consultant role supporting post-approval vaccines is described as remote. 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 role provides strategic CMC regulatory leadership for late-stage and marketed vaccine products. It helps maintain compliant product lifecycles by guiding submissions, health-authority interactions, and manufacturing-change assessments in collaboration with senior cross-functional partners.

What you'll do

• Develop CMC strategies for late-stage and marketed products
• oversee complex submissions, including applications, variations, supplements, and responses to health-authority questions
• author and review submissions
• lead regulatory CMC discussions and agency interactions
• address reviewer comments
• assess manufacturing changes and submission requirements
• represent Regulatory CMC in project teams and governance committees
• advise senior management
• mentor team members
• monitor evolving regulations and industry practices.

What we're looking for

Skills & competencies

senior regulatory affairs consultant

cmc

post-approval vaccines

regulatory strategy

health authority engagement

regulatory submissions

manufacturing changes

lifecycle management

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

Senior-level CMC strategy and health-authority engagement focused on post-approval vaccine products.

About the employer

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