Senior Regulatory Affairs Associate – Generalist

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee U.S. regulatory archive logs, document new submissions, archive correspondence from regulatory authorities, and manage communications with global partners.

• Ensure that regulatory records are indexed, version-controlled, comprehensive, audit-ready, and compliant through the use of RIM, EDMS, or other relevant archiving tools.

• Maintain tracking systems for Form FDA 1572 waiver requests and clinical regulatory documentation.

• Perform GLP reviews of study documentation to ensure IND-level compliance.

• Write 1572 waiver requests and assist with routine regulatory submissions for clinical investigators.

• Act as a representative for Regulatory Affairs in cross-functional clinical trial meetings, providing regulatory interpretation, updates, and risk assessments.

• Prepare administrative components of submissions, which include FDA forms, cover letters, metadata, and supporting documents.

• Develop and organize electronic submission frameworks and oversee internal workflows and approvals.

• Manage submission package delivery via publishing workflows and liaise with submission/publishing teams.

• Create materials for Global Regulatory Team, governance, and alliance meetings.

• Represent Regulatory Affairs in partner and alliance meetings, provide updates, and monitor action items.

• Contribute to FDA meeting requests, briefing documents, special designation applications, IND submissions, and amendments.

• Prepare, review, and submit PADERs, NDA Annual Reports, DSURs, and PBRERs.

• Monitor post-approval commitments, submission timelines, and global regulatory obligations.

• Assist with lifecycle management activities and ensure ongoing product compliance.

⛳️ Requirements

• A minimum of 3 years of relevant regulatory affairs experience within an industry-related environment.

• At least a Bachelor’s Degree in a Scientific or Technical Discipline.

• An advanced degree is preferred.

• Knowledge of project management principles.

• A client-focused approach to work.

• Strong results orientation.

• Ability to work effectively in teams and collaborate with others.

• Proficient consulting skills.

• Exceptional written and verbal interpersonal and intercultural communication abilities.

• Strong critical thinking and problem-solving capabilities.

• Proficiency in the local language.

• Extensive working knowledge of English.

• Preference for candidates residing in the Eastern or Central time zones of the US or Canada.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements and a supportive work environment.