Regulatory Affairs Manager

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Company: Katalyst HealthCares and Life Sciences

Location: Springfield, IL 62704

Description:

Responsibilities:
  • Oversee the preparation and review of dossiers and documents, ensuring timely renewal of facilities and product licenses in the US, Canada, and other countries.
  • Monitor regulations by FDA, Health Canada, COFEPRIS, ANVISA, and others, designing strategies for compliance with new and existing regulations.
  • Create, motivate, lead, and evaluate small to mid-size teams to achieve department and corporate goals.
  • Work with the Director in budgeting, regulatory strategy, goal setting, and motivation of team members.
  • Coordinate cross-functional teams and consultants, managing the regulatory team and organizing weekly meetings for tracking RA projects and tasks.
  • Strategic Planning and Implementation:
  • Assist the Director in managing and leading strategy formulation and implementation to create greater efficiency and improve regulatory processes.
  • Organize regulatory strategies into PowerPoint presentations and reports for the RA Director and other GCA/GCIAG executives.
  • Communication and Coordination:
  • Organize and moderate weekly departmental meetings.
  • Communicate feedback from the RA team to the Director and other stakeholders.
  • Coordinate RA team to work with QA and Marketing teams to ensure updated QMS and regulatory compliance of marketing promotional materials.
  • Operational and Vendor Management:
  • Support the Director of Regulatory Affairs in vendor relationship management and evaluation of proposals prior to Director approval.
  • Work with Legal to ensure NDAs with third parties are up to date.
  • Manage the cross-functional team responsible for the preparation of dossiers for regulatory submission, overseeing documentation formatting and maintenance within the documentation management system.
Requirements:
  • A minimum of a bachelor's degree in a science field required.
  • Experience in Management and Regulatory Function in Pharma, Device or Healthcare.
  • Experience in Management and Regulatory Affairs.
  • US and Global Managerial and Regulatory experience, Leadership, P&L Experience.
  • Experience with FDA and Other US regulatory bodies required.

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