Associate Principal Regulatory Writer

A company is looking for an Associate Principal Regulatory Writer (APRW) - Clinical.

Key Responsibilities

Lead development of strategies for organizing and preparing regulatory documents in collaboration with clients and internal teams

Author high-quality regulatory documents and manage the review process, ensuring compliance with client specifications and regulatory guidelines

Provide mentorship to junior staff and ensure adherence to company standard operating procedures (SOPs)

Required Qualifications

Bachelor's degree; MS or PhD preferred

8+ years of regulatory writing experience or equivalent experience with clinical sections of the CTD

Strong understanding of regulatory authority guidelines and requirements

Experience in developing submission-level documents

Intermediate proficiency with Microsoft Word and document management techniques