Senior Regulatory Affairs Specialist

Company Description

Dyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment.

Role Description

on-site

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field.
• 5+ years of experience in regulatory affairs with a focus on eCTD and CTD submissions for both regulated and non-regulated countries.
• Hands-on experience with eCTD submission software.
• Experience with submission systems and document management processes.
• Experience with Regulatory Documentation, Regulatory Compliance, and Regulatory Requirements.
• Proficiency in Regulatory Affairs and Regulatory Submissions.
• Strong understanding of global regulatory standards and procedures.
• Excellent attention to detail and organizational skills.
• Strong communication skills, both verbal and written.
• Ability to work collaboratively in an on-site setting.
• Problem-solving skills and the ability to troubleshoot technical issues related to client's eCTD submissions.

Key Responsibilities

• Develop and manage our own eCTD software tool for the creation, validation, and submission of regulatory dossiers for all the regions
• Stay up to date with the latest regulatory guidelines, standards, and requirements related to eCTD/CTD submissions.
• Continuously review and analyze regulatory trends and changes to ensure ongoing compliance and implementation of industry's best practices.
• Conduct troubleshooting and resolve any issues related to eCTD/CTD submission formats and software functionality for our clients.
• Provide training and support to Development Team on the use of RA tools and best practices.
• Conduct quality checks on our software and ensure they adhere to submission guidelines.
• Assist in making our software more robust, user friendly and easy to use.
• Keep up to date with new regulatory developments and technological advancements related to eCTD/CTD submissions and ensure team members are informed.
• Collaborate with clients to ensure all their submission-related requirements are met for successful filings.