Senior Regulatory Affairs Lead — Partnerships & Submissions

Parexel; Concord (NH); Remote; 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 across development and commercial programs. This role handles end-to-end regulatory affairs for partnered assets, coordinating with internal teams and alliance stakeholders to ensure regulatory excellence from clinical to post-approval activities.

The position involves regulatory planning, documentation management, submissions, and ongoing compliance with

Qualifications

• 3+ years of related regulatory affairs experience in the pharmaceutical industry.
• Experience supporting partnered assets and cross-functional teams.
• Knowledge of FDA, ICH and global regulatory requirements.

Responsibilities

• Regulatory archiving and documentation management for submissions and correspondence.
• Clinical regulatory support including Form FDA 1572 and GLP reviews.
• Draft administrative components of regulatory submissions and manage submission planning.
• Coordinate submission packaging and liaise with publishing teams.
• Prepare materials for Global Regulatory Team meetings and alliance discussions.
• Support post-approval regulatory maintenance and lifecycle activities.

Skills

Project management

Client-focused

Results oriented

Teamwork & collaboration

Consulting skills

Interpersonal communication

Critical thinking & problem solving

English language proficiency

Education

Bachelor's degree in a scientific or technical discipline

Advanced degree preferred

Job description

Parexel is seeking a highly organized Regulatory Affairs Generalist / Senior Associate to support a strategic pharmaceutical partnership across development and commercial programs. This role handles end-to-end regulatory affairs for partnered assets, coordinating with internal teams and alliance stakeholders to ensure regulatory excellence from clinical to post-approval activities.

The position involves regulatory planning, documentation management, submissions, and ongoing compliance with