Pulmovant is looking for a Senior Manager of Regulatory Documentation and Operations to manage the documentation and regulatory operations infrastructure. You will oversee all regulatory publishing and document management needs, ensuring the accuracy and timeliness of submissions.
What You'll Do
- Perform hands-on document formatting and regulatory publishing.
- Ensure all documents and submissions are error-free and meet internal and external deadlines.
- Implement SOPs and work processes for documentation, publishing, submissions, and archiving.
- Work with regulatory strategists, CMC strategists, and project team members to execute the regulatory strategy.
What We're Looking For
- A BA/BS degree is required.
- 7+ years of pharmaceutical industry experience.
- 5+ years in regulatory affairs with knowledge of FDA submission expectations.
- Proven ability to handle all aspects of regulatory operations, including document and submission processing.
- Solid experience using Microsoft Word and Adobe PDF files with Veeva RIM and DocuBridge systems.
- Experience successfully completing IND and/or NDA/BLA submissions activities.
- A solution-oriented, highly collaborative team player with excellent verbal and written communication skills.
- Must command respect from peers, be capable of highly independent work, and act as a team player and role model.
- A highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in a rapidly growing company.
Nice to Have
- Additional experience with ex-US regulatory submissions.
- Experience handling medical device submissions and post-approval activities.
Technical Stack
- Microsoft Word
- Adobe PDF
- Veeva RIM
- DocuBridge
Team & Environment
You will work with regulatory strategists, CMC strategists, and project team members, reporting to the SVP of Regulatory Affairs and Quality.
Work Mode
This is a remote position open to candidates located in the US.
Pulmovant is an equal opportunity employer.
