Principal Regulatory Affairs Lead (CRO) – Remote

About This Opportunity

We are representing a confidential contract research organization that provides regulatory strategy and execution services to biotech and pharmaceutical clients. Our talent team is seeking a Principal Regulatory Affairs Lead to serve as the primary U.S. regulatory presence for this growing CRO. This is a fully remote, W-2 position based in the United States.

In this role, you will act as the U.S. agent communicating directly with the FDA on behalf of sponsors, oversee regulatory project delivery from consultation through submission and maintenance, and serve as a mentor to junior team members. You will work autonomously within a globally distributed environment, owning projects end-to-end while collaborating with international stakeholders.

Responsibilities

• Serve as U.S. agent for FDA communications on behalf of sponsors, distributing updates promptly and guiding responses to Information Requests
• Deliver regulatory projects including preparation and execution of consultation meetings, IND/NDA submissions and maintenance, CMC document authoring and review, gap analysis, and ad-hoc regulatory consultation
• Manage regulatory projects as Project Manager or Lead, ensuring timely delivery that meets client and internal quality standards, including system updates for time entry, project status, and financial matters
• Support business development and commercial activities by participating in client meetings, seminars, webinars, and conferences
• Provide mentoring and technical guidance to team members on regulatory services and best practices
• Build and maintain a network of industry colleagues through project engagements and professional activities
• Proactively identify and propose resolutions to project challenges or conflicts using technical expertise

What We're Looking For

• Education: Bachelor's degree in Life Sciences, Clinical Research, or related field required; advanced degree preferred
• Experience: Previous CRO or pharmaceutical industry experience required, with extensive knowledge of FDA regulations
• Regulatory Expertise: Deep understanding of IND submissions, CMC requirements, and regulatory communication strategies
• Documentation Skills: Proven ability in authoring, reviewing, and performing gap analysis of regulatory documents including INDs and CMC sections
• Project Management: Demonstrated success managing regulatory projects with attention to scope, timeline, quality, and budget
• Technical Proficiency: Strong skills in MS Office Suite, MS Teams, TMF management systems, and internet-based platforms
• Communication: Excellent written and verbal English communication for interfacing with clients, regulatory authorities, and internal teams
• Work Style: Highly autonomous, comfortable working independently in a remote, globally distributed environment
• Professional Skills: Strong problem-solving, sound judgment, decision-making, presentation, and organizational abilities

How We Work With You

Candidates apply directly through Get A Job.ai. Our recruiting team will conduct an initial screening to understand your background and regulatory expertise. Qualified candidates will then be submitted to our client for consideration. Please do not attempt to contact the client directly, as all communication must flow through our talent team to ensure a professional process for all parties.

Pay

Compensation details will be discussed with qualified candidates during the screening process.

Equal Opportunity: Get A Job.ai is committed to inclusive recruiting practices and works with clients who value diverse talent pools.