Regulatory Affairs

Roles and Responsibilities

· Responsible for formatting and publishing, of regulatory documents (PMA, Design Dossier, Health Authority Responses, etc., IND, CTA, NDA, and others as needed) in paper and/or electronic formats.

· Ensure documents are submitted using formats and styles essential for regulatory compliance with established operating procedures, and current medical and technical writing standards.

· Maintain current knowledge of internal and external document formatting and regulatory publishing requirements and industry best practices.

· Compilation and publishing of routine submission to PMAs (new applications, notifications, supplement), INDs (safety reports, investigator information, protocol amendments, etc.), NDAs (original submissions, supplements, responses), etc., on a routine basis.

· Control submission component receipt and workflow completion to ensure a high-quality final submission.

· Coordinate publishing tasks associated with assigned submissions, including peer review of submissions generated by other publishers.

· Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted.

· Ability to contribute to brainstorming and troubleshooting of technical issues that impact validation requirements for submission dispatch.

· Dispatch submissions through the FDA Gateway.

· Maintenance of electronic and hardcopies files.

· Create and maintain templates for regulatory documents and submissions.

· Provide regulatory operations support to the Regulatory Affairs team.

· Other duties as needed.

Education and Experience:

· Bachelor's degree desired or equivalent relevant professional experience in Regulatory Publishing/Operations.

· A minimum of 2 years related experience in publishing/Regulatory Operations in the biotechnology or pharmaceutical industries.

· Basic understanding of the US, EU, and ICH publishing regulations and guidelines.

· Excellent computer skills, including proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Office) and Adobe Professional.

· Proficiency in publishing regulatory documents and using regulatory e-submission software e-Submitter, FDA validation software, ISI Toolbox.

· Previous hands-on experience with compiling documents for routine IND, NDAs, Amendments, Supplements submissions in paper and eCTD format.          Experience with PMA publishing is preferable.

· Proficiency in scanning and standard graphics software.

· Ability to work independently with minimal supervision.

· Strong verbal and written communication skills.

· Ability to multitask, pay close attention to detail, and follow projects through to completion. Excellent organizational, prioritization, and planning skills

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