As a Regulatory Affairs Manager, you will be the primary point of contact for clients navigating the FDA regulatory process. You will lead regulatory strategy and submissions, manage cross-functional expert teams, and ensure key milestones and timelines are met across multiple drug development projects simultaneously. This is a fully remote, individual contributor role working with US-based clients and teams in Eastern Time.

What You'll Do

• Advise clients on FDA regulations, policies, and guidance applicable to CDER and CBER
• Serve as US Agent or Regulatory Contact on behalf of sponsor clients in FDA interactions
• Lead the regulatory process for FDA Meetings, INDs, DMFs, ODDs, and product lifecycle submissions
• Provide regulatory strategy and guidance on FDA requirements for meetings and applications
• Lead and coordinate Subject Matter Expert (SME) teams to ensure deliverables are met on time and within budget
• Identify critical regulatory issues and develop strategies to address them in collaboration with SMEs
• Prepare, format, and quality-review regulatory documents in compliance with FDA guidelines for Module 1
• Collaborate on proposal development and follow up on outstanding proposals
• Share regulatory intelligence and best practices across the team
• Mentor colleagues and contribute to internal SOPs and process improvement
• Support client relationship management and business development activities

• Bachelor's or advanced degree in life sciences, biology, regulatory affairs, or a related healthcare field
• 3+ years of regulatory affairs experience in biotech, pharma, or drug development
• 2+ years supporting cross-functional project teams
• US Agent or Regulatory Contact experience — required
• Working knowledge of FDA regulatory guidelines and ICH regulations for drugs and biologics
• Intermediate experience with eCTD modules, submissions, and the drug development process
• Familiarity with regulatory tools such as Vantagepoint, StartingPoint templates, Smartsheet, or similar platforms
• Advanced proficiency in Microsoft Word document formatting
• Strong project management skills — ability to manage multiple projects in parallel
• Proactive, collaborative, and able to work independently with a high standard of quality

• RAC certification (Regulatory Affairs Certification — RAPS)
• Exposure to marketing applications: BLAs, NDAs, ANDAs, Biosimilars
• Prior experience in a regulatory consulting environment managing multiple client accounts