Regulatory Affairs Manager - CMC

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.,

• Write CMC sections (23S, 23P, 32S, 32P) 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
  
  10+ years of experience in regulatory affairs
• Extensive knowledge of CMC writing and variations strategy
• 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
• Proficiency in English; additional languages are a plus
Preferred Qualifications:
• Experience with regulatory agencies (e.g., FDA, MHRA)
• Industry-recognized certifications or advanced degrees
• Publication history or experience presenting at industry conferences
  
  When you join us, you're joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there's no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change - forever. And together, we'll do it With Heart ., Parexel is among the world's largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.