Regulatory Compliance Manager

2 weeks ago

Tarrytown, New York, United States EPM Scientific Full time

Job Summary:

The Manager, Regulatory Compliance will lead a team in assembling and discussing site-wise and cross-departmental issues, overseeing investigations, and completing Field Alert forms for regulatory authorities. This role is responsible for managing product recalls, temporary workforce staffing, tracking responses, and report writing. Additionally, the Manager will support the establishment, revision, and maintenance of Global Quality Standards.


Key Responsibilities:

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


Requirements:

Education:

  • Bachelor's Degree in a science-related field – Required.


Experience:

  • A minimum of 5 years 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.
  • Ability to work independently while leading a team and fostering a collaborative environment.
  • Experience in data analysis for identifying trends and generating metrics and reports.
  • Strong verbal and written communication skills.
  • Technical writing skills and the ability to apply critical thinking to assess and evaluate complex Field Alert events and issues effectively.


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.

  • Regulatory Compliance Manager

    3 weeks ago

    Tarrytown, New York, United States EPM Scientific Full time

    Job Title: Regulatory Affairs ManagerAt EPM Scientific, we are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of quality in our operations.Key Responsibilities:Lead and manage the...

  • Quality Assurance Specialist

    2 days ago

    Tarrytown, New York, United States Emerge Talent Cloud Full time

    Job SummaryThe Quality Assurance Specialist plays a critical role in ensuring the quality and safety of our products. This position is responsible for supporting the QA Manager in maintaining compliance with regulatory requirements and industry standards.The ideal candidate will have a strong understanding of cGMP requirements and be able to analyze data to...

  • Senior Compliance Risk Manager

    4 weeks ago

    Tarrytown, New York, United States M&T Bank Full time

    Job SummaryWe are seeking a highly skilled Senior Compliance Advisor to join our team at M&T Bank. As a key member of our Compliance Department, you will play a critical role in ensuring the bank's compliance with regulatory requirements and maintaining a strong risk management culture.Key ResponsibilitiesProvide compliance oversight and guidance to Wealth,...

  • Regulatory Affairs Director

    1 day ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryThis is an exciting opportunity to lead the work of a team advancing Regeneron's pipeline in general medicine within the Regulatory Strategy group in Regulatory Affairs.The incumbent will lead a group of highly motivated individuals working to develop approaches to study candidate therapeutics in general medicine with a focus on cardiovascular and...

  • Regulatory Affairs Director

    13 hours ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryThe Director of Regulatory Affairs will provide strategic leadership on global regulatory activities for assigned products. Key responsibilities include providing regulatory expertise, developing strategic plans, and ensuring compliance with regulations and project timelines.Key Responsibilities:Provide interpretation of regulatory authorities'...

  • Regulatory Affairs Director

    5 days ago

    Tarrytown, New York, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at BioSpace, Inc. This is a key leadership role that will provide strategic direction and guidance on global regulatory activities for our assigned products.Key ResponsibilitiesProvide leadership on global regulatory activities, including clinical regulatory filings and...

  • Regulatory Affairs Director

    3 weeks ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job Title: Director, Regulatory Affairs StrategyRegeneron Pharmaceuticals is seeking a highly skilled and experienced Director, Regulatory Affairs Strategy to lead our global regulatory activities for assigned products. As a key member of our team, you will provide strategic leadership on clinical regulatory filings and regulatory leadership on project...

  • Senior Manager, Regulatory Intelligence Expert

    3 weeks ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryWe are seeking a highly skilled Senior Manager, Regulatory Intelligence to lead our global monitoring and surveillance efforts in the regulatory landscape. This role will be responsible for providing critical regulatory intelligence to support our drug development lifecycle, from preclinical to commercialization.Key ResponsibilitiesLead the...

  • Executive Director, Regulatory Affairs Lead

    4 days ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryThis is an exciting opportunity to lead the work of a team advancing Regeneron's vibrant pipeline in the area of general medicine within the Regulatory Strategy group in Regulatory Affairs.Key ResponsibilitiesLead a group of highly motivated individuals working to develop approaches to study candidate therapeutics in the area of general medicine...

  • Associate Director Regulatory Affairs Strategy

    5 days ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryWe are seeking an experienced Associate Director Regulatory Affairs Strategy to provide leadership on global regulatory activities for our assigned products. The successful candidate will be responsible for providing regulatory leadership on project teams, interpreting regulatory authorities' feedback, and developing regulatory strategic plans.Key...

  • Senior Risk Manager

    3 weeks ago

    Tarrytown, New York, United States Citizens Full time

    Job Title: First Line Risk Senior ManagerCitizens is seeking a highly skilled and experienced First Line Risk Senior Manager to join our team. As a key member of our risk management function, you will be responsible for identifying, assessing, and mitigating risks across our Wealth Management business.Key Responsibilities:Develop and implement risk...

  • Regulatory Clinical Trials Veeva Solutions Expert

    4 days ago

    Tarrytown, New York, United States Abode Techzone LLC Full time

    Job Title: Regulatory Clinical Trials Veeva ConsultantAbode Techzone LLC is seeking a highly skilled Regulatory Clinical Trials Veeva Consultant to join our team.Main Responsibilities:Experience working with Regulatory and Quality area in Clinical trials.Lead Solution reviews for the project and get it approved from review board.Familiarity with Architecture...

  • First Line Risk Senior Manager

    3 weeks ago

    Tarrytown, New York, United States Citizens Full time

    Job Title: First Line Risk Senior ManagerCitizens is seeking a highly skilled First Line Risk Senior Manager to join our team. As a key member of our risk management team, you will be responsible for identifying and mitigating potential risks within our Private Wealth Management business.Key Responsibilities:Actively engage in the identification and...

  • Senior Compliance Specialist

    2 days ago

    Tarrytown, New York, United States Ampcus Full time

    Job Summary: We are seeking a highly skilled Senior Compliance Specialist to join our team at Ampcus. As a key member of our engineering organization, you will be responsible for ensuring compliance with normative necessities, managing codes and standards, and providing procedural support for engineering activities.Key Responsibilities:Manage and coordinate...

  • Environmental Health and Safety Manager

    3 weeks ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals Full time

    Job SummaryWe are seeking a highly skilled Environmental Health and Safety Manager to join our team at Regeneron Pharmaceuticals. As a key member of our EH&S department, you will be responsible for ensuring the health and safety of our employees, visitors, and the environment.Key ResponsibilitiesDevelop and implement EH&S policies, procedures, and programs...

  • Quality Systems Specialist

    3 days ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full time

    Job Summary: We are seeking a highly skilled Quality Systems Specialist to join our team at Regeneron Pharmaceuticals, Inc. The successful candidate will be responsible for ensuring compliance with all aspects of quality for our manufacturing site, inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials...

  • Healthcare Operations Manager

    4 weeks ago

    Tarrytown, New York, United States MVP Health Care Full time

    About the RoleMVP Health Care is seeking a skilled Leader, Enrollment Operations to join our team. As a key member of our organization, you will be responsible for developing and maintaining accurate staffing models, participating in audit-related activities, and reconciling enrollment data with State-Based entities.Key ResponsibilitiesDevelop and maintain...

  • Quality Systems Specialist

    3 weeks ago

    Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full time

    Job Summary:The Quality System Specialist participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations.Key...

  • EH&S Manager

    1 month ago

    Tarrytown, New York, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly skilled EH&S Manager to lead our team in ensuring a safe and healthy work environment. As a key member of our EH&S department, you will be responsible for developing and implementing effective health and safety programs, procedures, and policies.Key ResponsibilitiesDevelop and implement EH&S programs, procedures, and...

  • Nurse Manager

    3 weeks ago

    Tarrytown, New York, United States Northwell Health Full time

    Job SummaryWe are seeking a highly skilled and experienced Nurse Manager to join our team at Northwell Health. The successful candidate will be responsible for managing, scheduling, and assessing the performance of clinical staff in the department.Key ResponsibilitiesLeadership and Management: Develop and implement strategies to improve patient care and...