Description
We are seeking a Regulatory Submissions Coordinator to provide regulatory support for assigned projects in Brazil.
The successful candidate will prepare and review regulatory submissions documents to support marketing authorization and post-approval activities for internal and external clients.
Responsibilities:
- Perform timely updates to regulatory databases following approvals, variations, renewals, extensions, and other lifecycle activities
- Manage the creation, review, and maintenance of regulatory documents and records in accordance with established procedures
- Support change control assessments by evaluating the regulatory impact of proposed product, manufacturing, labeling, and quality changes
- Collaborate with cross-functional teams, including Regulatory Affairs, Quality, Manufacturing, Supply Chain, and Pharmacovigilance, to maintain current regulatory information
- Track and maintain regulatory commitments, submission milestones, and approval documentation
- Support preparation and maintenance of regulatory dossiers and lifecycle submissions
- Contribute to process improvements related to regulatory information management and document maintenance
- Ensure compliance with applicable regulatory requirements and internal quality standards
Qualifications:
- Bachelor's Degree in Life Sciences or related discipline
- At least 2 years of relevant experience in lifecycle maintenance, assessment, preparation and submission of post-registration, and regulatory information systems
- Hands-on experience with CADIFA, including maintenance of regulatory documentation, product records, and lifecycle management data
- Fluent conversational English
- Ability to work effectively in a team environment and build positive working relationships across functions