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Global Regulatory Compliance Specialist
vor 2 Wochen
Job Title: Manager/ Senior Manager Global Regulatory Operations
Description: This role requires a seasoned professional to lead and manage global regulatory operations, ensuring compliance with ICH specifications and Health Authority regulations.
About the Job
The successful candidate will have extensive experience in document management systems, electronic publishing systems, and electronic submissions, including eCTD, CTAs, direct submission to global Health Authorities. The role involves planning, compiling, publishing, reviewing, and delivering compliant regulatory submissions to Regulatory Health Authorities in a timely manner.
Key Responsibilities:
- Ensure documents comply with submission-ready standards and guidelines.
- Maintain and archive all regulatory correspondence in appropriate systems.
- Liaise with vendors for submission support as needed.
- Participate in validation or verification testing of templates, electronic document management system, information management, and document/submission publishing related tools.
- Provide expertise and support to the user community for RIM systems and EDMS.
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.
- 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.
