About the Role
This role involves preparing and managing regulatory submissions, ensuring adherence to global standards, and supporting teams through all stages of product development and lifecycle management.
Responsibilities
- Prepare and submit regulatory documents to health authorities
- Ensure compliance with regional and international regulations
- Support the development of registration dossiers
- Coordinate with cross-functional teams on submission timelines
- Track and manage regulatory milestones
- Maintain up-to-date knowledge of regulatory requirements
- Assist in responding to agency queries
- Compile data for Investigational New Drug applications
- Support variation and supplement submissions
- Review labeling and packaging materials for compliance
- Participate in pre-submission meetings with agencies
- Monitor regulatory intelligence updates
- Contribute to CMC regulatory strategies
- Assist in due diligence for regulatory projects
- Manage electronic common technical document formatting
- Support post-approval regulatory commitments
- Facilitate communication between internal teams and regulators
- Ensure documentation meets audit readiness standards
- Assist in global regulatory strategy development
- Prepare meeting briefing documents for regulatory agencies
- Maintain regulatory databases and trackers
- Support expedited program applications
- Coordinate with external partners on joint submissions
- Provide input on regulatory risk assessments
- Assist in training team members on regulatory updates
Compensation
Competitive salary and benefits package
Work Arrangement
Hybrid work model available
Team
Collaborative team environment within regulatory affairs
Why Join Us
- Opportunity to work on diverse therapeutic projects
- Exposure to global regulatory strategies
- Professional growth in a fast-paced environment
- Collaboration with experienced regulatory experts
- Support for continuous learning and development
What We Offer
- Comprehensive benefits including health insurance
- Flexible work scheduling options
- Performance-based recognition programs
- Access to regulatory training resources
- Career advancement opportunities
Not available
