Senior Regulatory Affairs Manager - CMC bio/vax (various European locations - home or office based)

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global pharmaceutical environment. This is a client dedicated project, without people management responsibility. The role can be home or office based in various European locations. Key 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 Required Qualifications: 10+ years of experience in regulatory affairs Extensive knowledge of CMC writing and variations strategy Working knowledge of vaccines or biological processes - required Experience with regulatory agencies (e.g., FDA, EMA, MHRA) In-depth understanding of EU guidelines (Variation, ICH, EMA) Excellent project management and organizational skills Strong communication abilities and client management experience Ability to work independently and as part of a team Fluent in English written and spoken; additional languages are a plus