Regulatory Affairs Senior Associate — Partnerships Lead

Parexel; Harrisburg (Dauphin County); On-site; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a highly organized Regulatory Affairs Generalist / Senior Associate to support a strategic pharmaceutical partnership, handling end-to-end regulatory activities across clinical, submission, and post-approval stages.

This role works cross-functionally with internal teams and alliance partners to ensure regulatory excellence, robust documentation management, and timely submissions, with emphasis on planning, risk assessment, and regulatory compliance.

Qualifications

• 3+ years of regulatory affairs experience in an industry-related environment.
• Familiarity with FDA submissions, GLP reviews, and IND processes.
• Experience drafting regulatory documents and managing submission components.

Responsibilities

• Regulatory Archiving & Documentation Management across programs, ensuring audit readiness.
• Clinical Regulatory Support including 1572s, GLP reviews, and IND submissions.
• Regulatory Submission Preparation: draft and organize submission components and metadata.
• Global Regulatory Team (GRT) collaboration and alliance meeting participation.
• Authoring & Reviewing Regulatory Submissions: FDA meeting requests, briefing documents, and designations.
• Post Approval Regulatory Maintenance: prepare and submit PADERs, NDA annual reports, DSURs, and PBRERs.

Skills

Project management

Client-focused

Regulatory terminology

Cross-functional collaboration

Communication skills

Problem-solving

English proficiency

Education

Bachelor’s Degree in Science/Technical Field

Job description

Parexel is seeking a highly organized Regulatory Affairs Generalist / Senior Associate to support a strategic pharmaceutical partnership, handling end-to-end regulatory activities across clinical, submission, and post-approval stages.

This role works cross-functionally with internal teams and alliance partners to ensure regulatory excellence, robust documentation management, and timely submissions, with emphasis on planning, risk assessment, and regulatory compliance.