Senior Associate, Submission Operations - Remote

Overview

This position supports Regulatory Affairs personnel in the coordination, preparation, and submission of all INDs/NDAs/MAAs and life cycle management of these submissions in both paper and electronic format to global health authorities.

In Short

• Act as lead publisher for major applications.
• Provide leadership to plan resources and deliver on strict timelines.
• Responsible for report level publishing and submission level compilation.
• Perform document management tasks including file transfer, storage, and archival.
• Review and contribute to the implementation of standards and procedures.
• Act as mentor to junior resources.
• Assist in the evaluation and implementation of software.
• Strong knowledge of submission requirements for all types.
• Ability to work under challenging deadlines.
• Travel as required (Approximately 10%).

Requirements

• A minimum of 5+ years in the biotechnology or pharmaceutical industry.
• Regulatory operations experience within a regulated environment.
• Experience with CTD/eCTD structure and format.
• Strong knowledge of EU, US health authority and ICH regulations.
• BA/BS Degree in life science or computer science preferred.

Benefits

• Comprehensive benefits package including Medical, Dental, Vision.
• 401(k), FSA/HSA, Life Insurance.
• Paid Time Off and Wellness initiatives.
• Opportunity to own shares of BeOne Medicines Ltd. stock.
• Participation in incentive compensation plans.