Description
Specific responsibilities include but are not limited to:RESPONSIBILITES:
- Assist to ensure the successful preparation and filing of all regulatory submissions including INDs/CTAs, NDA/MAAs, amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, etc.
- Review documents for completeness and compliance with regulatory requirements
- Provide administrative and related project support
- Contact company employees to gather information and prepare reports
- Establish standards for document preparation, timeline development/management, and procedures to receive final, submission ready documents in eCTD format.
- Provide formatting support for documents to ensure consistency within and between documents and with document templates
- Support production, assembly and publishing of submission documents
- Responsible for data entry, filing, archiving, and maintenance of submission tracking databases.
- Create and maintain regulatory standard operating procedures
- Perform regulatory research and regulatory intelligence as needed.
- Perform other regulatory affairs functions as necessary.
Qualifications:
- Bachelor's degree in the sciences or other disciplines, or equivalent industry experience.
- A minimum of 3 years with global clinical trial applications and support.
- Strong understanding of the drug development process, excellent communication skills, both oral and written as well as a strong attention to detail.
- Electronic submissions experience is a plus.
- Effective planning and organizational skills and strong computer skills including MS Word experience