Sobre esta vaga de Senior Regulatory Affairs Manager - CMC bio/vax (various European locations - home or office based) na Parexel
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
