Senior Manager of Regulatory Documentation and Operations, Pulmovant

Pulmovant

11h

About The Position

The Senior Manager of Regulatory Documentation and Operations will be responsible for managing the documentation and regulatory operations infrastructure and overseeing with the regulatory publishing and document management needs for Pulmovant. This position in consultation and alignment with the SVP of regulatory affairs and quality is accountable for all regulatory operations activities. This includes regulatory document formatting and finalization, archiving, submissions planning, publishing, QC, and submissions. The role will require direct hands-on contributions. A successful candidate must have significant experience using Microsoft Word, Adobe PDF, Veeva RIM, and DocuBridge handling a variety of regulatory submissions from early phase through post-approval. US FDA experience is essential, global experience is strongly preferred.

Requirements

• BA/BS degree required with 7+ years of pharmaceutical industry experience with 5+ years in regulatory affairs
• Knowledge of FDA submission expectations is required. Additional experience with ex-US is preferred.
• 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. Preferred if also handled medical device submissions and post-approval 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior