Maintain U.S. regulatory archive logs, including: Recording new submissions; Archiving regulatory authority correspondence; Upload and manage correspondence from global partners for assigned programs; Ensure proper indexing, version control, and compliance using Regulatory Information Management (RIM) systems, electronic document management systems (EDMS), or other applicable archiving tools; Ensure records are complete, audit ready, and aligned with internal SOPs and regulatory expectations.
Maintain and update trackers for Form FDA 1572 waiver requests and other clinical regulatory documentation.
Conduct GLP reviews of study documentation on behalf of Regulatory Affairs to support IND level compliance.
Author 1572 waiver requests and support routine regulatory submissions for clinical investigators.
Draft administrative components of regulatory submissions, including: FDA forms; Cover letters; Submission metadata and other supporting documents; Build and organize electronic submission structures using RIM systems or industry standard submission planning tools.
Prepare presentation materials and slide decks for Global Regulatory Team (GRT) meetings, governance discussions, and alliance meetings.

5+ years of related regulatory affairs experience in an industry-related environment
Project management knowledge
Client-focused approach to work
Results orientation
Teamwork and collaboration skills
Consulting skills
Excellent interpersonal and intercultural communication skills, both written and verbal
Critical thinking and problem-solving skills
Proficiency in local language and extensive working knowledge of the English language.

Regulatory Affairs Consultant – Regulatory Generalist

Key skills