Regulatory Affairs- eCTD Specialist

Regulatory Affairs Hiring Profile eCTD Specialist

Experience Level:

Location:

Skills & Qualifications:

1.Education: Bachelor's or Masters degree in Life Sciences, Regulatory Affairs, or related field.

2.Experience: 3 to 6 years of experience in regulatory affairs with a focus on eCTD submissions, preferably in the pharmaceutical or biotechnology industry.

Role Overview:

With 3 to 6 years of experience in regulatory affairs, this role requires expertise in eCTD submission software, strong knowledge of global regulatory standards, and the ability to troubleshoot and improve submission processes. The specialist will ensure compliance with evolving regulatory guidelines, provide support and training to teams, and collaborate with clients to meet submission requirements.

Technical Skills:

o Hands-on experience with eCTD submission software (e.g., Veeva Vault QMS, Lorenz DocuBridge, eCTDExpress etc.).

o Strong knowledge of global regulatory requirements (FDA, EMA, PMDA, etc.) and eCTD formatting standards.

o Familiarity with submission systems and document management processes.

Soft Skills:

• Excellent attention to details and organizational skills.
• Strong communication skills, both written and verbal.
• Ability to work independently and collaboratively with clients.
• Problem-solving skills and the ability to troubleshoot technical issues related to clients 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 submissions.
• Continuously review and analyze regulatory trends and changes to ensure ongoing compliance and implementation of industrys best practices.
• Conduct troubleshooting and resolve any issues related to eCTD submission formats and software functionality for our clients.
• Provide training and support to Development Team on the use of eCTD tools and best practices.
• Conduct quality checks on our eCTD tool and ensure they adhere to submission guidelines.
• Assist in making our eCTD software more robust, user friendly and easy to use.
• Keep up to date with new regulatory developments and technological advancements related to eCTD submissions and ensure team members are informed.
• Collaborate with clients to ensure all their submission-related requirements are met for successful filings.