Summary

Responsibility for managing and maintaining existing development and marketing authorization dossiers and compiling submissions in compliance with ICH specifications and Health Authority regulations globally. Co-ordination with functional leads in various disciplines to ensure compliant documents, maintain regulatory information and the physical and electronic regulatory archives, mentor on eCTD requirements and other duties and/or special projects as assigned or required.

Duties and Responsibilities

• Responsible for the timely planning, compiling, publishing, review and delivery of compliant regulatory submissions to Regulatory Health Authorities.
• Ensures documents comply with submission ready standards and guidelines and provides guidance with respect to requirements.
• Maintains and archives all regulatory correspondence in appropriate systems.
• Liaises with vendors for submission support, as needed.
• Participates in validation or verification testing of templates, electronic document management system, information management and document/submission publishing related tools.
• Provides expertise and support to the user community for RIM systems and EDMS.
• Maintains tracking tools and systems for regulatory information, including submission content plans.
• Support other areas of the company (eg., Business Development) concerning regulatory documentation, as needed.
• Maintains current working instructions for regulatory-related systems (e.g. publishing software, RIM and EDMS.
• Mentors others on submission processes and requirements and may manage contract Regulatory Operations personnel.
• Contribute positively to a strong culture of business integrity and ethics.
• Act within compliance and legal requirements as well as within company guidelines.
• Coordinate the preparation and review of documents for regulatory submissions (e.g. cover letters, forms, DSURs, safety reports, etc.).
• Participates in the preparation of dossiers containing manufacturing, preclinical, and clinical data.
• Provides guidance to authors for clear document and data presentation and location in order to optimize submission navigation as well as the regulatory review and approval process.
• Analyze and continuously improve work practices and guidelines and organize and conduct training on behalf of the Regulatory Operations team as appropriate.
• Remain current on knowledge of industry trends relevant to global electronic submissions and interface systems with Health Agencies for all regions

Requirements

• Bachelor degree (in science, technology, health- related field, or business management preferred) or equivalent experience.
• Minimum of three years’ experience for Manager and five years’ experience for Sr. Manager in a regulatory affairs environment with document management systems, electronic publishing systems and electronic submissions, including eCTD, CTAs, direct submission to global Health Authorities.
• Experience in drug development and knowledge of global regulatory submission content and formats.
• Experience with packaging and labelling, and combination products submissions preferred.
• Strong technical knowledge and working skills in publishing and related computer software including advanced MS Word, Adobe and Adobe plug-ins.
• Excellent organization, communication and writing skills.
• Ability to manage multiple priorities and projects.
• Strong attention to detail and quality.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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