Greater Philadelphia Area
about 1 year ago
A biopharmaceutical company of ours has a new opening for a Manager of Regulatory Affairs role located in the Greater Philadelphia area. This individual will be responsible for ensuring activities for the US are complete and assisting with EU/ROW registration activities by supporting all regulatory functions and contributing to ongoing development activities.
- Prepare IND and NDA submissions, clinical trial applications, amendments, safety updates, meeting requests, briefing packages, supplements, annual reports, etc.
- Document regulatory activities with all Health Authorities such as the FDA
- Participate as an active member of a multi-disciplinary team to develop regulatory strategies for late stage and early development programs as well as commercialized products
- Identify potential risks associated with regulatory strategies
- Provide in depth review of protocols, reports, presentations, and other regulatory documents
- Assist in managing internal review of all submissions and documents
- Ensure completeness, accuracy, and consistency adhering to all regulations and guidelines for submissions
- At least 5 years of regulatory experience
- Understanding of regulations, guidelines, and strategic application for drug development at IND and NDA stages
- Experience with eCTD submissions
- Excellent verbal and written communication skills
This role is actively interviewing candidates, please send your CV to Marissa, at email@example.com for consideration.