Senior Regulatory Affairs Specialist – Remote

Parexel; Bismarck (ND); Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a highly organized Regulatory Affairs Generalist / Senior Associate to support regulatory activities for partnered assets across clinical, submission, and post-approval phases. You will collaborate with internal teams and alliance stakeholders to ensure regulatory excellence in planning, documentation, and execution.

The role involves cross-functional collaboration, attention to detail, and the ability to manage multiple priorities in a dynamic partnership environment.

Qualifications

• 3+ years of regulatory affairs experience in pharma/biotech.
• Excellent oral and written communication in English.
• Experience with regulatory planning and document management.

Responsibilities

• Maintain regulatory archives and manage submissions using RIM/EDMS systems.
• Provide regulatory input in cross-functional alliance meetings and risk assessments.
• Draft submission components including FDA forms, cover letters, and metadata.
• Support post-approval regulatory activities and lifecycle management.

Skills

Project management

Client-focused

Teamwork

Interpersonal communication

Problem-solving

English proficiency

Education

Bachelor’s degree in science/technical

Job description

Parexel is seeking a highly organized Regulatory Affairs Generalist / Senior Associate to support regulatory activities for partnered assets across clinical, submission, and post-approval phases. You will collaborate with internal teams and alliance stakeholders to ensure regulatory excellence in planning, documentation, and execution.

The role involves cross-functional collaboration, attention to detail, and the ability to manage multiple priorities in a dynamic partnership environment.