Senior Regulatory Affairs Manager - CMC bio/vax

Responsibilities

• Write CMC sections and scientific rationales for regulatory submissions and responses

• 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 proposal preparation

Requirements

• 10+ years of experience in regulatory affairs

• Extensive knowledge of CMC writing and variations strategy

• Working knowledge of vaccines or biological processes

• Experience with regulatory agencies (FDA, EMA, MHRA)

• In-depth understanding of EU guidelines (Variation, ICH, EMA)

• Excellent project management and organizational skills

• Strong communication and client management experience

• Fluent in English written and spoken

Preferred Qualifications

• Additional languages

About the Company

Parexel is a global clinical research organization supporting pharmaceutical and biotech development. The role is a client-dedicated project without people management responsibility.