Senior Regulatory Affairs Specialist (Remote)

Parexel; Columbia (SC); Remote; USD 85,000 - 120,000; Full time

Job summary

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

The role involves regulatory planning, documentation management, and submission execution while collaborating with internal teams and alliance stakeholders to ensure regulatory excellence for partnered assets.

Qualifications

• Bachelor’s degree in a scientific or technical discipline.
• 3+ years of regulatory affairs experience.
• Experience with FDA submissions and regulatory documentation.
• Ability to work across clinical, submission, and post-approval activities.
• Strong written and verbal communication.

Responsibilities

• Maintain US regulatory archive logs and manage submission documentation.
• Support clinical regulatory documentation and IND compliance.
• Prepare draft administrative components of regulatory submissions.
• Coordinate submission packages and established publishing workflows.
• Support cross-functional governance meetings and alliance interactions.
• Prepare post-approval regulatory reports (PADERs, NDA Annual Reports, DSURs).

Skills

Regulatory affairs

Project management

Cross-functional collaboration

Regulatory submissions

Communication skills

Problem-solving

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, providing end-to-end regulatory affairs support across clinical, submission, and post-approval activities.

The role involves regulatory planning, documentation management, and submission execution while collaborating with internal teams and alliance stakeholders to ensure regulatory excellence for partnered assets.