Senior Regulatory Affairs Manager, CMC – Vaccines (EU)

Parexel; United States; Hybrid; USD 101,000 - 169,000; Full time

Job summary

Parexel is seeking a Senior Regulatory Affairs Manager/Consultant with 10+ years of regulatory affairs experience, including CMC expertise. The role offers diverse projects, client relationship management, and regulatory strategy contributions in a global pharmaceutical setting.

This client-dedicated position has no people management responsibility and can be home or office based in various European locations. Fluency in English is required, additional languages are a plus.

Qualifications

• 10+ years of experience in regulatory affairs.
• Extensive knowledge of CMC writing and variations strategy.
• Working knowledge of vaccines or biological processes is required.
• Experience with FDA, EMA, MHRA regulatory agencies.
• Strong understanding of EU guidelines (Variation, ICH, EMA).
• Excellent project management and client management skills.

Responsibilities

• Write CMC sections and rationales for regulatory submissions.
• Develop and implement variations strategies based on EU guidelines.
• Coordinate CMC activities across multiple projects.
• Liaise with global affiliates and manufacturing sites.
• Provide project leadership and management.
• Ensure client satisfaction and project quality.
• Identify new business opportunities and contribute to proposals.

Skills

CMC writing

Regulatory strategy

Project management

Client management

EU guidelines

English proficiency

Job description

Parexel is seeking a Senior Regulatory Affairs Manager/Consultant with 10+ years of regulatory affairs experience, including CMC expertise. The role offers diverse projects, client relationship management, and regulatory strategy contributions in a global pharmaceutical setting.

This client-dedicated position has no people management responsibility and can be home or office based in various European locations. Fluency in English is required, additional languages are a plus.