Manager, Regulatory Affairs - Tactical Implementation

About the role

We're seeking a Manager, Regulatory Affairs, Tactical Implementation for our Regulatory Affairs team. Reporting to the Associate Director, you'll play a key role in executing and overseeing global regulatory submission activities for assigned projects.

Responsibilities

• Support aspects of tactical implementation for assigned projects including project timeline planning and documentation workflow management for global regulatory documents (INDs/CTAs, NDA/BLAs, MAA, amendments, annual reports)
• Author and oversee the preparation of regulatory documents and meeting materials (e.g., meeting requests, briefing books, cover letter forms, etc.) ensuring clarity, accuracy, and consistency
• Lead document workflows throughout document lifecycles for regulatory documents, including creation, review, approval, revision, distribution, and archival
• Afford assistance in preparing and organizing all comments received from regulatory agencies and manage and/or track the company's planned response
• Partner with Regulatory Strategies and act as a point of contact for cross-functional teams (Clinical, Nonclinical, CMC) to ensure effective coordination and execution of regulatory deliverables
• Maintain submissions and correspondence and archive regulatory files using Veeva Vault Document Management System
• Contribute to the development and improvement of regulatory systems, tools, and procedures to enhance efficiency and quality

Requirements

• Bachelor’s degree in relevant field
• 5+ years of experience in Regulatory Affairs in the pharmaceutical or biotechnology industry

Qualifications

• Excellent organizational and time management skills to manage multiple ongoing projects simultaneously to meet tight deadlines
• Knowledge and understanding of regulations and guidances
• Excellent communications skills (written and verbal)
• Efficient, detail-oriented, flexible, and a self-starter
• Able to work in different document repository and sharing database
• Proficient in MS Office applications (Word, Excel, PowerPoint, Outlook), Adobe Acrobat

Skills

• Nice to have (but not required): Preferred experience in SmartSheet or other project management software

Where You’ll Work

This is a fully remote role. Occasional travel for team meetings or events will be expected. Pay Range: $133,000.00 - $173,000.00 Annual