Senior Regulatory Affairs Manager - CMC bio/vax (various European locations - ho
TypeFull-time job
LocationCroatia, Hungary, Ireland, Italy, Poland
Posted3 hours ago
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
Originally posted on Himalayas
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
Originally posted on Himalayas
Apply on Himalayas →
Job sourced from Himalayas. Applications happen directly on the original platform — we never collect your data.