Director of Regulatory Affairs

02 Jan, 2022


Director of Regulatory Affairs

Amador Biosciences
Remote (MD)

Position Summary

The Director of Regulatory Affairs will lead the development and implementation of the global regulatory strategy for Amador Bioscience. This individual will be responsible for developing and executing a global strategy for the department and must possess the ability to develop and maintain communications with FDA, and coordinate interactions with regulatory agencies in EU, US and Asia.

Key Responsibilities

  • Acts as lead subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and oversees key client projects. Provides internal clients with up -to-date and emerging legislation and guidance.
  • Accountable for the delivery of all regulatory milestones based on a thorough assessment of regulatory risks and mitigations. Provide regulatory direction with expected scientific data, regulatory guidance and precedent.
  • Participate in and promote novel regulatory initiatives internally and externally and lead the development of novel regulatory tools and technology.
  • Work closely with the Business Development team to grow Amador Bioscience business. Participates in new business development activities including, but not limited to, client meetings and proposal preparation/presentation.
  • Provide regulatory advice to cross-functional teams to achieve timely and efficient regulatory submissions while ensuring compliance with applicable regulatory requirements.

Qualifications and Education Requirements

  • Advanced degree in sciences related degree and/or business management and a minimum of 10 years work related experience. A minimum of 5 years of experience in clinical R&D and/or clinical research organizations/CRO focused on regulatory affairs.
  • Advanced, broad understanding of global regulatory affairs procedures for clinical trial authorization and lifecycle management.
  • Demonstrated ability to develop and implement global regulatory strategies, facilitate approvals, resolve complex issues, and negotiate optimal regulatory pathways.
  • Expert knowledge of ICH and other global regulatory guidelines and in-depth understanding pre-clinical and clinical of a regulatory affairs laws and processes.
  • Demonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, briefing documents, and response to federal agencies.
  • Ability to think strategically and critically and evaluate risks to regulatory activities.
  • Global perspective with a demonstrated ability to work across functions, regions, and cultures.
  • Comprehensive knowledge of Good Laboratory Practices (GLP) requirements and demonstrated experience in client service in the CRO environment.
  • Demonstrated ability to use appropriate interpersonal styles and techniques to develop internal networks and lead negotiations with internal and external stakeholders.

Learn more here

Job posted: 2022-01-02