Associate Director, Regulatory Publishing

Key Duties & Responsibilities

• Manages portfolio views of upcoming submissions and publishing interdependencies and serves as Global Regulatory Publishing subject matter expert
• Serve as primary point of contact between cross‑functional team and regulatory publishing vendor.
• Monitor vendor KPIs, SLAs, and quality metrics; escalate performance issues or capacity constraints.
• Stay current on regulatory publishing trends and best practices, and assess implications for internal processes and vendor partnerships, and ensure vendor adherence to company SOPs, global regulatory requirements, and evolving health authority guidance.
• Partner with cross‑functional teams to develop and manage submission publishing timelines, publishing strategy, and resource forecasting.
• Ensure submission content is tracked, compiled, validated, and delivered in the required format in compliance with regional requirements.
• Perform quality control (QC) reviews on vendor work to ensure submission content meets regulatory and internal standards.
• Lead or contribute to the development and continuous improvement of publishing processes, templates, checklists, and SOPs.
• Participate in cross‑functional or global working groups focused on submission process innovation or regulatory technology and provide training or guidance to stakeholders on publishing timelines and requirements.
• Contribute to long‑term resource planning, including publishing capacity needs.

Bachelor’s Degree in life sciences or technology area

Typically requires 9 years of Regulatory Operations/Publishing experience or the equivalent combination of education and experience.

• Extensive experience in industry‑standard publishing software and validation systems
• Vendor management/outsourcing experience
• Ability to prioritize a portfolio of publishing activities on selected programs
• Ability to train and educate other team members and influence cross‑functional stakeholders in submission‑ready concepts
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Strong organization, written/verbal communication, and attention to detail
• Knowledge of health authority procedures/guidance regarding electronic submissions.
• Expert in Electronic Document Management Systems.

Through the end of the year, with the chance to extend

$90/hr.

- $100/hr.

Monday - Friday. EST hours. Remote.