Director, Regulatory Affairs

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 experiencedDirector of Regulatory Affairsto 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.
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.
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.
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).
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.
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.
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).
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.
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.
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.
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.
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.
Communication:Exceptional scientific/medical writing skills, with a proven ability to distill complex data into clear, persuasive regulatory narratives.
* Operational Independence:Prove