About the Role
This role supports regulatory operations with a focus on contract management and documentation, requiring strong Italian language skills to ensure accurate communication and compliance within a dedicated client environment.
Responsibilities
- Manage regulatory documentation for submissions in Italian and English
- Support contract lifecycle processes within regulatory frameworks
- Coordinate with internal teams to ensure compliance with regulatory standards
- Track and maintain regulatory databases for assigned projects
- Prepare and review regulatory correspondence in Italian
- Assist in the preparation of regulatory applications and renewals
- Ensure timely submission of regulatory deliverables
- Liaise with cross-functional teams to gather required documentation
- Maintain accurate records of regulatory communications
- Monitor regulatory timelines and escalate potential delays
- Provide Italian language support for regulatory queries
- Assist in audits and inspections by preparing necessary documentation
- Follow standard operating procedures for regulatory submissions
- Support the maintenance of product dossiers in compliance with local requirements
- Coordinate with external partners on regulatory updates
- Participate in project meetings related to regulatory timelines
- Ensure consistency of regulatory information across departments
- Support change control processes within regulatory systems
- Review translation accuracy for Italian regulatory content
- Assist in training team members on regulatory processes
- Maintain knowledge of evolving Italian regulatory requirements
- Support the integration of regulatory data across systems
- Prepare status reports for regulatory milestones
- Contribute to process improvement initiatives in regulatory operations
- Ensure confidentiality and data integrity in all regulatory activities
Compensation
Competitive market rate commensurate with experience
Work Arrangement
Hybrid work model with both remote and on-site components
Team
Part of a specialized regulatory affairs team serving a dedicated pharmaceutical client
Client Dedicated
Position is assigned exclusively to a single pharmaceutical client’s regulatory needs
FSP
Role operates under a Functional Service Provider model, integrating within the client’s team structure
Not available for this position
