Regulatory Affairs Manager; Chicago Area, IL

The Regulatory Affairs Manager reports to and assists the Director of Regulatory Affairs and Product Engineering. This position supports and assists the Director in formulating regulatory strategies, managing the team to implement the strategies in the day-to-day operations of the department, ensuring and maintaining regulatory compliance in the US, Canada, Latin America, and assigned Asian countries, in accordance with the goals of client companies, divisions, and departments to achieve revenue and profit goals.

ESSENTIAL DUTIES and RESPONSIBILITIES:

• Understanding of chemistry, and years of managerial and regulatory experience working with FDA and other US regulatory agencies in pharma and healthcare. Experience in managerial and regulatory functions in the pharma, device, or healthcare industry helps maintain good relationships with external and internal clients and improves regulatory compliance.
• Management experience in managing small to mid-size teams with experience creating, motivating, leading, and evaluating the team to achieve department and corporate goals. The Senior Manager works with the Director in budgeting, regulatory strategy, goal setting, and motivation of team members and evaluates regulatory team members. Manages the regulatory team.
• Experience in strategic planning and implementation, assisting the Director to manage and lead strategy formulation and implementation to create greater efficiency and improve regulatory processes.
• Management experience with budgeting and P & L responsibility, B2B experience to support the Director of Regulatory Affairs in vendor relationship management and evaluation of proposals prior to Director approval.
• Organizes and moderates the weekly departmental meeting presided over by the Director.
• Managerial skills in creating, managing, and leading the team to achieve regulatory, product registration, and revenue objectives of the client. Ability to organize, plan, coordinate, and work with the team, communicate via Teams and PowerPoint presentations to the RA team, client executives, and implement regulatory plans with the regulatory team.
• Change control and LTF process management and other FDA, EPA, LATAM regulations to support and assist the Director and ensure regulatory compliance across the coverage areas.
• Assists the Director in preparing departmental reports as and when required.
• Sets targets for product registrations in RA across countries and supervises the implementation to ensure client meets sales and revenue objectives.
• The Regulatory Affairs Manager coordinates the RA team, organizes the team, leads projects, works with the team in setting timelines, controls costs by reviewing invoices, proposals with inputs before Director approval.
• Manages the cross-functional team and consultants responsible for the preparation of dossiers for regulatory submission, oversees coordinating of documentation formatting and maintenance within the documentation management system.
• Communicates the feedback from the RA team to the Director and any other stakeholder, organizes weekly meetings for tracking RA projects and tasks to ensure timely completion, evaluates and works with the team to close any compliance gaps.
• Development of SOPs, RA job descriptions, RA process improvement reports, and review of compliance with regulatory contracts. Proficiency in Microsoft Office (Excel, Word, PowerPoint).
• Coordinates RA team to work with QA and marketing team to ensure updated QMS and regulatory compliance of marketing promotional materials.
• Participates in meetings with other teams, within client and other locations to coordinate regulatory responses and ensure global compliance.
• Responsible for regulatory impact and documentation of change control within client.
• Operational contact for RA by global teams in all GC countries on regulatory issues and clarifications.
• Manages regulatory team responsible for operational regulatory tasks, projects, including coordination, preparation, and review of dossiers and documents. Ensures that facilities and product licenses are renewed before they fall due in the US, Canada, and other countries.
• Works with legal to ensure NDAs with third parties are up to date.
• Monitors regulations by FDA, Health Canada, COFEPRIS, ANVISA, and others. Designs strategies to ensure compliance with new regulations, communicates, and motivates the team to achieve regulatory compliance. Works with the LATAM manager and business team and RA in Mexico and Brazil to achieve registration plan and revenue goals in the region.
• Manages complex new regulations by FDA, EPA, and Health Canada. Works with the Director and consultants to design strategies for compliance with new and existing regulations.
• Organizes regulatory strategies into PowerPoint presentations and reports for the RA Director and other client executives.
• Works cross-functionally with both colleagues and the executives which requires good communication and…