Job 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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