Senior Associate/Manager Regulatory Affairs
Sr. Associate/Manager, Regulatory Affairs
MediVector is seeking a highly motivated regulatory affairs senior associate/manager to support current Phase 3 clinical studies. The Regulatory Affairs Senior Associate/Manager will, under appropriate supervision, provide general administrative support in the areas of document preparation and coordination and control in support of clinical programs for worldwide regulatory filings. Specific responsibilities include but are not limited to:
Summary of Key Responsibilities:
- 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.
- Bachelor’s degree in the sciences or other disciplines, or equivalent industry experience.
- A minimum of 3 years with European and/or Rest of World 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
Qualified candidates should submit resume with cover letter to: James L. McEvoy at: email@example.com