Senior Regulatory Affairs Leader - Remote

Emmes; Rockville (MD); Remote; USD 130,000 - 170,000; Full time

Benefits offered by this job

Flexible Approved Time Off

Tuition Reimbursement

401k Retirement Plan

Work From Home Anywhere in the US

Maternal/Paternal Leave

Casual Dress Code & Work Environment

Job summary

Emmes is seeking a Manager, Regulatory Affairs to lead regulatory strategy for multiple clinical development programs. The role combines advisory leadership with hands-on regulatory submissions and a focus on US FDA interactions, INDs, and approval pathways.

Based in the United States with remote work options, you will manage a team of Regulatory Affairs professionals, mentor staff, and ensure timely, compliant deliverables across projects and client engagements.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• 6–8+ years of Regulatory Affairs experience in CRO/pharma/clinical research.
• 1–3 years of management experience.
• Experience leading regulatory activities and submissions.
• Strong knowledge of global regulatory requirements.

Responsibilities

• Lead regulatory activities for development programs and studies.
• Develop and oversee regulatory strategies aligned with objectives.
• Prepare and submit regulatory documents to authorities.
• Guide cross-functional teams and manage regulatory risks.
• Support FDA interactions and client meetings.

Skills

Regulatory leadership

People management

Regulatory strategy

FDA familiarity

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Emmes is seeking a Manager, Regulatory Affairs to lead regulatory strategy for multiple clinical development programs. The role combines advisory leadership with hands-on regulatory submissions and a focus on US FDA interactions, INDs, and approval pathways.

Based in the United States with remote work options, you will manage a team of Regulatory Affairs professionals, mentor staff, and ensure timely, compliant deliverables across projects and client engagements.