Regulatory Affair Manager
Job Description
Disclaimer Pre-Launch Test Posting Notice
- Review study budgets and costing about contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs
- Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions
- Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff. Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country-specific requirements
This job posting is currently published for testing and platform validation purposes during the pre-launch phase of MedicalHealthcareJobs.com, a platform developed to support the global Healthcare and Life Sciences recruitment ecosystem. Visitors may also stay updated with the latest industry news through our website while additional employers, recruiters, and opportunities are progressively onboarded.
Healthcare professionals are encouraged to sign up as a Jobseeker and start building their career profiles while we gradually onboard employers and recruiters to bring more opportunities to the platform.
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