Director, Regulatory Affairs

somewhere; United States; Remote; USD 180,000 - 260,000; Full time

Benefits offered by this job

Remote work (100%)

Independent contractor

Job summary

somewhere seeks an experienced Director of Regulatory Affairs to serve as Global Regulatory Lead across its drug development portfolio, designing global regulatory strategies and leading cross-functional submission teams. You will manage health authority interactions, guide lifecycle management, and ensure alignment across clinical, nonclinical, and CMC activities in a fast-paced environment.

The position is offered as an Independent Contractor with 100% remote work and requires strategic

Qualifications

• Bachelor’s degree in life sciences or related field.
• 10+ years in biotechnology/pharma with regulatory affairs focus.
• Proven global regulatory strategy experience and health authority interactions.
• Excellent scientific/medical writing and clear regulatory storytelling.

Responsibilities

• Global Leadership: serve as Global Regulatory Lead for development programs.
• Strategy Execution: develop and execute program-level regulatory strategies.
• Risk Management: identify regulatory risks and create mitigation plans.
• Submission Leadership: lead cross-functional submissions and lifecycle activities.
• Cross-Functional Alignment: align clinical, nonclinical, and CMC teams to deadlines.
• Agency Interactions: plan meetings, prepare regulatory questions and filings.
• Correspondence & Designations: manage health authority communications and special programs.
• Feedback Integration: translate authority feedback into development actions.

Skills

Regulatory leadership

Global regulatory strategy

Health authority engagement

Regulatory submissions

Scientific writing

Education

Bachelor's degree in life sciences

Job description

Director, Regulatory Affairs

Engagement Type: Independent Contractor Agreement (100% Remote)

Department: Regulatory Affairs

Reports To: Vice President, Regulatory Affairs / Executive Management

Position Overview

We are seeking an experienced Director of Regulatory Affairs to serve as a Global Regulatory Lead across our drug development portfolio. In this role, you will be responsible for designing and executing comprehensive global regulatory strategies, leading cross-functional submission teams, and managing direct interactions with health authorities. The ideal candidate brings deep expertise in regulatory strategy, clinical development, and health authority engagement, along with the agility to thrive in a fast-paced environment.

Key Responsibilities

Regulatory & Program Oversight

• Global Leadership: Serve as the Global Regulatory Lead for assigned development programs across the entire portfolio.

• Strategy Execution: Develop, maintain, and execute robust, program-level regulatory strategies aligned with corporate goals and specific development stages.

• Risk Management: Proactively identify potential regulatory risks and author actionable mitigation strategies aligned across clinical, nonclinical, and CMC development plans.

Regulatory Submission Planning & Health Authority Engagement

• Submission Leadership: Lead cross-functional strategy and planning for regulatory submissions, amendments, and lifecycle management activities (e.g., annual reports, safety updates).

• Cross-Functional Alignment: Ensure seamless regulatory integration across clinical, nonclinical, and CMC submission components, aligning internal teams to meet target submission dates.

• Agency Interactions: Lead strategic planning for health authority meetings—developing meeting objectives, briefing documents, regulatory questions, and core positioning to guide interactions and inform program decisions.

• Correspondence & Designations: Oversee health authority correspondence, official submissions, and follow-ups. Author and manage applications for special regulatory programs (e.g., Orphan Drug, Fast Track, Priority Review, and other expedited pathways).

• Feedback Integration: Document, interpret, and integrate health authority feedback into ongoing development strategies and coordinate timely, accurate responses to regulatory inquiries.

Qualifications & Experience

Required

• Education: Bachelor’s degree in life sciences or a related scientific discipline.

• Experience: Minimum of 10 years in biotechnology or pharmaceutical development, with significant focal experience in Regulatory Affairs.

• Track Record: Demonstrated success leading or supporting global regulatory strategy, health authority interactions, and major submissions for early- to late-stage clinical programs.

• Communication: Exceptional scientific/medical writing skills, with a proven ability to distill complex data into clear, persuasive regulatory narratives.

• Operational Independence: Proven ability to operate effectively, strategically, and independently within a dynamic clinical development setting.

Preferred

• Advanced Degree: M.S., Ph.D., PharmD, or J.D. in a relevant field.

• EU Regulatory Expertise: Hands-on experience navigating the European Medicines Agency (EMA) processes and the Clinical Trials Information System (CTIS).

• Specialized Modalities: Direct experience with radiopharmaceuticals or specialized therapeutic platforms.

Contract Terms & Working Conditions

• Classification: Independent Contractor (100% Remote / Virtual).

• Flexibility: Remote structure requiring self-direction, reliable high-speed connectivity, and the ability to collaborate across global time zones.