Regulatory Affairs Manager

2 months ago

Tarrytown, United States EPM Scientific Full time

Description:

The Manager, Regulatory Compliance will assemble and lead a team for site-wise and/or cross-departmental discussions, oversee investigations, and complete Field Alert forms for issues and events that require notification to regulatory authorities such as the Food and Drug Administration (FDA). This role is responsible for managing product recalls, overseeing temporary workforce staffing, tracking responses, monitoring effectiveness checks, follow-up, closure, and report writing related to product recalls or market withdrawals. Additionally, the Manager will support the establishment, revision, and maintenance of current Global Quality Standards.


Essential Functions:

  • Act as the primary contact for the FDA and other regulatory agencies regarding Field Alerts, working closely with these agencies on resolutions and the establishment and revision of Global Quality Standards.
  • Manage and lead Global Notification Meetings with senior management and support the dissemination of RAPID Alert escalations for Field Alert submissions.
  • Prepare and maintain FAR status reports for executive management, assist in completing Field Alert (FD 3331a) forms as needed, and maintain and distribute reports on Field Alerts, recalls, and drug notifications, including the completion of Illegitimate Drug Notification 3911 forms to the FDA when necessary.
  • Lead and manage the recall workforce, including staffing requisitions, assigning work, monitoring performance, and approving timecards to support ongoing recalls.
  • Prepare for recalls by creating recall packages, completing Attachment B forms, and generating and submitting status reports to the FDA.
  • Oversee the internal processing of Field Alerts, support investigations, schedule follow-up meetings with site and management teams, and maintain metrics and progress spreadsheets.
  • Compile, analyze, and report on field alerts and recalls to management as required, creating and maintaining relevant metrics.


Additional Responsibilities:

  • Foster a positive working environment and build relationships with cross-functional partners and temporary workforce members.
  • Ensure that Global Quality Standards and Corporate Standard Operating Procedures (SOPs) are kept current concerning Field Alerts, recalls, etc.
  • Support the growth of the organization and the department to achieve company and departmental goals while maintaining compliance with regulatory requirements.
  • Promote a culture of teamwork, collaboration, accountability, and continuous improvement.
  • Engage directly with Site Quality Heads regarding investigations related to Field Alerts.
  • Write trend analyses and risk assessments as needed.


Qualifications:

Education:

  • Bachelor’s Degree (BA/BS) in a science-related field – Required.


Experience:

  • A minimum of 5 years demonstrating progressive responsibility in maintaining and enforcing Good Manufacturing Practices (GMPs) and Regulatory Compliance, with leadership experience.
  • At least 3 years of management experience overseeing people, projects, or functional areas, or a combination of these.
  • Minimum 2 years of thorough knowledge of FDA current Good Manufacturing Practices (cGMPs) (21 CFR Parts 210 & 211) and Part 820 requirements, with an understanding of ISO, EU, and ICH requirements.
  • Minimum 2 years managing Field Alert and Recall processing systems in the pharmaceutical, medical device, or related industries.


Skills:

  • Comprehensive knowledge and experience with Microsoft applications, including spreadsheet and database maintenance (Intermediate level).
  • Ability to work independently while leading a team and fostering a collaborative environment (Advanced level).
  • Experience in data analysis for identifying trends and generating metrics and reports (Intermediate level).
  • Strong verbal and written communication skills (Advanced level).
  • Technical writing skills and the ability to apply critical thinking to assess and evaluate complex Field Alert events and issues effectively (Intermediate level).


Specialized Knowledge:

  • Direct hands-on experience in the manufacturing or development of drug products or medical devices is a plus.
  • Strong knowledge of computerized software and electronic systems, such as Caliber.

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