Senior Regulatory Affairs Associate- Clinical Trial Application
ParexelBellandur, BangalorePosted 19 days ago
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About the role
Parexel provides clinical development and consulting services to the life sciences industry. This person plans and coordinates global clinical trial submissions, manages regulatory documentation and risks, and ensures compliance across submission activities.
What you'll do
- Lead clinical trial application projects across studies and countries
- Plan and deliver submissions across EU CTR and other regions
- Manage regulatory documentation throughout the submission lifecycle
- Identify and mitigate risks in global regulatory environments
- Coordinate submission execution with clinical, regulatory, and operations teams
- Monitor submission timelines and quality, and lead investigations as needed
Skills
Must have
- Clinical trial submissions
- Eu CTR
- Regulatory affairs
- Project management
- Clinical trial processes
- Regulatory requirements
Who it's for
- Education
- Bachelor's degree
- Degree
- life sciences, pharmacy
- Experience
- 5+ years
- Domain
- clinical research
About Parexel
Parexel has 18 open roles in Bangalore, at Parexel International - RMZ Ecoworld. See every Parexel role.
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