
Regulatory Compliance Specialist
1 week ago
We are seeking a skilled Regulatory Compliance Specialist to join our team. In this role, you will be responsible for ensuring the technical congruency and regulatory compliance of our products in the US market.
Main Responsibilities:- Develop high-quality CMC documentation for US FDA submissions in accordance with latest guidances.
- Identify required documentation for US regulatory submissions and negotiate delivery of approved technical source documents.
- Review and identify content, quality, and timeliness issues with source documents.
- Maintain knowledge up-to-date with regard to regulatory guidelines and requirements.
- Coordinate with stakeholders on regular basis to provide technical support from regulatory perspective.
- Hands-on experience using eCTD software and attending e-publishing requirements throughout project lifecycle.
- Strong technical knowledge, review skills, and understanding of regulatory submissions.
- Expertise in CTD/eCTD requirements for submission of dossiers.
- Able to try new approaches when faced with challenges.
- Good analytical and learning attitude.
This is an exciting opportunity to work with a dynamic team and contribute to the success of our organization. If you have the skills and passion to succeed, we encourage you to apply.
About Us:We are a leading company in the industry, committed to delivering high-quality products and services. We offer a collaborative and supportive work environment, opportunities for professional growth, and a competitive compensation package.
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