Responsibilities
- Able and willing to do hands on document formatting and regulatory publishing.
- Responsible for all documents and submissions to be error free from a regulatory validation standpoint with submissions made on time to meet any internal or external requirements.
- Responsible and accountable for implementing SOPs and work processes for documentation, publishing, submissions and archiving.
- Works with regulatory strategists and CMC strategists and project team members to execute the regulatory strategy.
Requirements
- BA/BS degree required
- 7+ years of pharmaceutical industry experience with 5+ years in regulatory affairs
- Knowledge of FDA submission expectations is required
- Must be solution oriented
- Must be able to handle all aspects of regulatory operations (document and submission processing)
- Must have solid experience using Word and PDF files utilizing Veeva RIM and DocuBridge systems
- Have successfully completed IND and/or NDA/BLA submissions activities
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company
- Must be able to command respect from peers and capable of highly independent work as well as being a team player and role model
- Must be a highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company
Nice to Have
- Additional experience with ex-US is preferred
- Preferred if also handled medical device submissions and post-approval activities
Team
Reports to: SVP of Regulatory Affairs and Quality
Additional Information
- US FDA experience is essential, global experience is strongly preferred
- Will you now or in the future require visa sponsorship (including F-1/STEM OPT and employer based non-immigrant and immigrant visa sponsorship)?
- Are you legally authorized to work in the United States?
