Regulatory Affairs Coordinator
2 weeks ago
Join us as a Regulatory Data Coordinator and be a pivotal part of our team dedicated to maintaining compliance with ever-evolving regulatory requirements. In this role, you'll collaborate closely with internal and external stakeholders to gather and manage vital regulatory information, ensuring our systems are always up-to-date and accurate. Your expertise will drive our compliance efforts, from conducting audits to generating detailed reports that inform our strategic decisions. We value innovation and continuous improvement, so staying informed about industry best practices and emerging technologies will be key. If you are detail-oriented, proactive, and passionate about regulatory data management, we invite you to join our dynamic and supportive team.
ESSENTIAL ACCOUNTABILITIES:
•Maintain and update regulatory data within systems, ensuring accuracy, completeness, and timeliness of information.
•Collaborate with suppliers, and vendors to obtain necessary regulatory documentation and updates.
•Serve as the primary point of contact for internal departments and external partners regarding regulatory data inquiries and requests.
•Coordinate with regulatory affairs, quality assurance, and other relevant departments to gather required regulatory information for input into company's systems.
•Monitor regulatory changes and updates, ensuring that regulatory data within company's systems is kept up-to-date and compliant with current regulations.
•Conduct regular audits and quality checks of regulatory data to identify discrepancies, errors, or gaps and take corrective actions as needed.
•Generate reports and metrics related to regulatory data management for internal and external stakeholders.
•Stay informed about industry best practices and emerging technologies related to regulatory data management to enhance efficiency and effectiveness.
QUALIFICATION REQUIREMENTS:
•Bachelor's degree in a relevant field such as regulatory affairs, life sciences, or a related discipline required; or in lieu of degree, we will consider candidates with a combination of education and relevant experience.
•0-3 years of experience in comprehending legislative and regulatory frameworks, including but not limited to FDA, EPA, and TSCA guidelines.
•Requires excellent attention to detail, strong time management and communication skills, and a willingness to take the lead.
•Strong understanding of Microsoft Office (Excel, Word, PowerPoint, etc.) and Adobe Acrobat Pro.
•The ability to manage and organize large volumes of data effectively.
•Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
•Proficiency in using regulatory information systems, databases, and software applications.
•Knowledge of regulatory requirements and standards relevant to the organization's industry and products.
•Ability to work independently and prioritize tasks to meet deadlines in a fast-paced environment.
•Strong analytical and problem-solving skills, with the ability to identify and resolve data management issues.
•Commitment to continuous learning and professional development in the field of regulatory affairs and data management.
•Working knowledge of Microsoft office suite and Adobe Acrobat Pro.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
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