Senior Regulatory Affairs Associate
On-siteBengaluru, Karnataka, India
Bengaluru, Karnataka, IndiaOn-siteFull TimeSenior LevelEnterprise
Full TimeSenior LevelEnterprise
Job Summary
Senior Regulatory Affairs Associate at Parexel responsible for global regulatory lifecycle management across EU, US, and international markets; contribute to regulatory strategy and prepare, coordinate, and deliver regulatory submission packages (Modules 1–5); manage post-approval changes and health authority queries; support audit readiness and RIM system records; collaborate with project leads and stakeholders to ensure timely, quality regulatory deliverables.
Required Qualifications
- 5 to 8 years of relevant regulatory experience
- B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy
- Strong knowledge of EU & US regulatory procedures
- Experience in global submission management and lifecycle maintenance
- Understanding of regulatory documentation and compliance standards
- Strong coordination and stakeholder management skills
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