Regulatory Affairs Manager — Strategic Lead (US Remote)

The Emmes Company, LLC; Rockville (MD); Remote; USD 150,000 - 190,000; Full time

Benefits offered by this job

Work From Home Anywhere in the US

Tuition Reimbursement

401k Retirement Plan

Casual Dress Code & Work Environment

Job summary

The Emmes Company, LLC is seeking a Manager, Regulatory Affairs to lead regulatory strategy and biosafety-compliance for diverse clinical programs. This remote US role combines client-facing advisory work with hands-on regulatory execution, enabling effective dialogue with FDA and other agencies.

You will guide submissions, mentor a regulatory team, and ensure on-time, audit-ready deliverables while coordinating with cross-functional partners across Clinical Operations, Quality, Safety, and

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• 6–8+ years of regulatory affairs experience in CRO, pharma, biotech, or clinical research.
• 1–3 years of management experience and people leadership.

Responsibilities

• Lead regulatory activities for clinical development programs, studies, or client projects.
• Develop and oversee regulatory strategies aligned with objectives and regulatory requirements.
• Guide submissions and interact with authorities such as FDA, EMA, and others.
• Oversee regulatory operations to ensure timely, compliant submissions and audit readiness.
• Mentor up to 10 Regulatory Affairs employees and manage performance development.

Skills

Leadership

Regulatory affairs knowledge

Project management

Communication

People management

Education

Bachelor's degree in life sciences, pharmacy, healthcare, or related field

Advanced degree preferred

Job description

The Emmes Company, LLC is seeking a Manager, Regulatory Affairs to lead regulatory strategy and biosafety-compliance for diverse clinical programs. This remote US role combines client-facing advisory work with hands-on regulatory execution, enabling effective dialogue with FDA and other agencies.

You will guide submissions, mentor a regulatory team, and ensure on-time, audit-ready deliverables while coordinating with cross-functional partners across Clinical Operations, Quality, Safety, and