Overview
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.
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