Remote Senior Regulatory Affairs Generalist

Parexel; Des Moines (IA); Remote; USD 85,000 - 125,000; Full time

Job summary

Parexel is seeking a Regulatory Affairs Generalist / Senior Associate to support a strategic pharmaceutical partnership with end-to-end regulatory affairs for clinical, submission, and post-approval activities.

The role focuses on regulatory planning, documentation management, submission execution, and compliance within a dynamic cross-company environment, requiring strong communication and problem-solving skills.

Qualifications

• 3+ years of related regulatory affairs experience in an industry-related environment.
• Bachelor’s degree in a scientific or technical discipline or equivalent.
• Experience drafting, reviewing, and submitting regulatory documentation across development stages.

Responsibilities

• Regulatory Archiving & Documentation Management: maintain US regulatory archive logs, record submissions, archive correspondence, and ensure compliance.
• Clinical Regulatory Support: track Form FDA 1572 waivers and support IND-level regulatory documentation.
• Regulatory Submission Preparation: draft administrative components, build submission structures, and manage workflows.
• Global Regulatory Team (GRT) & Cross-Functional Collaboration: prepare materials for meetings and act as regulatory representative in alliance discussions.
• Authoring & Reviewing Regulatory Submissions: contribute to drafting and review across development phases including FDA meeting requests and applications for designations.
• Post Approval Regulatory Maintenance: prepare and submit PADERs, NDA annual reports, DSURs, and lifecycle commitments.

Skills

Project management

Client-focused

Results orientation

Teamwork

Consulting skills

Interpersonal communication

Critical thinking

English proficiency

Education

Bachelor’s Degree in a Scientific or Technical Discipline

Job description

Parexel is seeking a Regulatory Affairs Generalist / Senior Associate to support a strategic pharmaceutical partnership with end-to-end regulatory affairs for clinical, submission, and post-approval activities.

The role focuses on regulatory planning, documentation management, submission execution, and compliance within a dynamic cross-company environment, requiring strong communication and problem-solving skills.