24 Oct
PAREXEL
Great Britain
Job description
When our values align, there's no limit to what we can achieve.
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