Senior Regulatory Affairs Manager - CMC (various locations)

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 (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

Required Qualifications:

• 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