Product Owner

Key Skills and Qualifications:

• Education: Bachelors/Masters in Life Sciences, Business, or related field.
• Experience: Overall 15+ years of experience with expertise in eCTD publishing software and regulatory submissions.
• Knowledge: Deep understanding of eCTD standards, submission processes, and relevant regulatory guidelines.
• Skills:
• Strong analytical, communication, and collaboration skills.
• Familiarity with XML, validation tools, and other eCTD-related technologies is preferred.
• Ability to work independently, prioritize tasks, and manage multiple projects simultaneously.
• Attention to detail and strong organizational skills.

Additional Information:

• Work Environment: Hybrid Travel Requirements: Occasional travel may be required.

eCTD Tool Development & Support:

• Develop and update the eCTD submission tool and related software applications.
• Provide user training and support for internal teams on the proper use of eCTD tools.
• Monitor system performance and assist in software upgrades, configuration changes, and troubleshooting.

Regulatory Compliance:

• Ensure that eCTD submissions adhere to regulatory guidelines and requirements (e.g., FDA, EMA).
• Stay updated on regulatory changes impacting eCTD submission standards.
• Support audits and inspections related to electronic submissions and regulatory compliance.

Collaboration:

Work closely with cross-functional teams, including Regulatory Affairs, IT, and Document Management to improve eCTD submission workflows and automation. ,

Develop and document standard operating procedures (SOPs) for eCTD submission processes and tool usage.