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ModeX Therapeutics Inc · 2 days ago

Associate Director, Global Regulatory Affairs

Weston, MA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

7+ years exp

ModeX Therapeutics Inc is focused on early-stage drug development, and they are seeking an Associate Director for Global Regulatory Affairs. This role involves developing and implementing regulatory strategies for drug development programs, serving as the regulatory lead, and collaborating with cross-functional teams to ensure successful regulatory submissions.

BiotechnologyManufacturing

Responsibilities

Prepare and support submission to successful filing and approval for clinical trial submissions

Develop various briefing packages and regulatory applications (e.g. orphan, expedited review pathways, etc.) to the FDA and other global health authorities, as applicable

Develop response and submission strategies to regulatory information requests in close collaboration with cross-functional team members

Partner with project team leaders and functional leaders to define project strategy, develop and maintain integrated project plans, and manage diverse teams across multiple sites to meet project timelines/goals

Continuously adapt project strategy based on internal and external information

Identify and assess regulatory risks for assigned projects or programs

Serve a Health Authorities contact for the assigned projects and contribute to Health Authority meetings

Foster effective, proactive and open communication within and across project teams, build mutual respect and trust among team members to achieve transparency and clarity of program goals, progress and issues

Contribute to development and improvement in processes, procedures, and tools related to regulatory affairs practices

Qualification

Regulatory AffairsDrug DevelopmentInterfacing with Regulatory AuthoritiesLife Sciences DegreeOrganizational SkillsInterpersonal SkillsProject ManagementTeam Collaboration