Regulatory Affairs Manager

3 weeks ago

St Louis, United States Harba Solutions Inc. Full time

Responsibilities:


  • Manage submissions and projects as assigned by Regulatory leadership, ensuring compliance, planning, and execution.
  • Represent regulatory interests on cross-functional teams.
  • Process, interpret, and provide recommendations for complex regulatory strategies.
  • Offer regulatory and technical expertise to cross-functional teams.
  • Critically review documentation for regulatory submissions and suggest necessary revisions.
  • Develop and implement regulatory strategies for CMC aspects of drug development and registration.
  • Lead the preparation and submission of CMC sections of regulatory documents (e.g., INDs, NDAs, BLAs, MAAs) in compliance with global regulations and guidelines.
  • Contribute to defining the Target Product Profile and create compliant drug dossiers for registration.
  • Serve as a liaison for third-party service providers.
  • Maintain a database to track individual and department project deliverables for regulatory submissions and milestones.
  • Develop and implement policies, procedures, practices, and strategies for Regulatory Affairs based on current Health Authority guidelines and regulations.
  • Manage multiple priorities, define issues and obstacles, conduct risk analysis, and execute solutions.
  • Execute objectives in alignment with Regulatory leadership, Marketing, and Global Business Units.
  • Communicate regulatory policy changes to management promptly and provide plans for compliance.
  • Understand and recommend strategies based on current local registration requirements and applicable industry standards.
  • Support the professional development of regulatory staff through mentorship and guidance.
  • Present updates and insights to upper management at required intervals, effectively communicating successes and challenges.
  • Maintain operational compliance with US and international regulatory agencies and guidelines (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).


Requirements:


  • Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities.
  • Ten or more years of relevant Regulatory Affairs pharmaceutical industry experience.
  • Two years of supervisory experience of direct reports required, matrix management experience preferred.
  • In-depth knowledge of global CMC regulatory requirements, guidelines, and industry practices.
  • Experience in leading new project submission efforts including strategy, compilation, submission, and approval by a health authority.
  • Experience writing Target Product Profiles, non-clinical studies, reviewing Clinical protocols and summary reports.

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