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Parabilis Medicines · 4 days ago

Associate Director, Regulatory Operations

United States

Full-time

Remote

Lead/Staff, Director/Executive

$165K/yr - $200K/yr

8+ years exp

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines. The Associate Director of Regulatory Operations will lead strategy, infrastructure, and execution for all regulatory submissions, ensuring timely, compliant filings with health authorities while managing teams and processes.

Biotechnology

Responsibilities

Define vision for Regulatory Operations, build scalable infrastructure, mentor teams, and provide solutions balancing compliance with business needs

Oversee lifecycle of submissions, from planning, formatting, publishing (eCTD), to archiving, managing health authority correspondence and commitments

Implement internal US eCTD submission and Regulatory Information systems including regulatory document templates

Drive continuous improvement, implement best practices, and develop standard operating procedures for efficient, lean operations

Partner with Regulatory Affairs, R&D, Quality, and Commercial teams to ensure integrated, compliant product development

Monitor global regulatory changes, assess impact, and advise leadership on strategy adjustments

Oversee relationships with external vendors and contractors for systems and technology

Qualification

ECTD expertiseRegulatory Information ManagementFDA guidelines knowledgeLeadership skillsProject managementAI tools usageCommunication skillsProblem-solving skills