Senior Regulatory Affairs Specialist — Remote

Parexel; Baton Rouge (LA); Remote; USD 90,000 - 150,000; Full time

Job summary

Parexel is seeking a Regulatory Affairs Generalist / Senior Associate in the United States to provide end-to-end regulatory support for partnered assets across development and commercial programs.

The role partners with internal teams and alliance stakeholders to ensure regulatory excellence in planning, documentation, and submissions, including post-approval activities. Requires strong communication, problem solving, and cross-functional collaboration.

Qualifications

• 3+ years of related regulatory affairs experience in an industry environment.
• Bachelor’s degree in a scientific or technical discipline required; advanced degree preferred.

Responsibilities

• Regulatory archiving & documentation management across regimes and programs.
• Clinical regulatory support including form FDA 1572 reviews and IND-level compliance.
• Prepare and manage regulatory submission components and metadata.
• Liaise in cross-functional Global Regulatory Team and alliance meetings to track deliverables.
• Author and review regulatory submissions across development phases including FDA meetings and designation applications.
• Post-approval regulatory maintenance including PADERs, NDA Annual Reports, DSURs, PBRERs.

Skills

Project management

Client-focused

Results orientation

Teamwork

Consulting skills

Interpersonal communication

Problem-solving

English language proficiency

Education

Bachelor’s degree in science/technology

Advanced degree preferred

Job description

Parexel is seeking a Regulatory Affairs Generalist / Senior Associate in the United States to provide end-to-end regulatory support for partnered assets across development and commercial programs.

The role partners with internal teams and alliance stakeholders to ensure regulatory excellence in planning, documentation, and submissions, including post-approval activities. Requires strong communication, problem solving, and cross-functional collaboration.