Specialist, Regulatory Affairs Operations Publishing

Position Summary

The incumbent with minimal assistance conducts and supports global regulatory affairs dossier publishing activities. Activities include document and submission preparation and review, communicating with RA staff and other subject matter experts, and updating regulatory submission trackers.

Performance Objectives

• Publishes regulatory affairs dossiers for submission to health authorities.
• Contributes to the development and implementation of dossier publishing processes and procedures to improve efficiency and meet health authority standards.
• Interacts with regulatory affairs and subject matter experts to ensure every published dossier meets health authority and ICH standards.

Education/Certification Requirements

• College degree in scientific field, technology, or related discipline, or equivalent experience is required.
• Advanced skills in eCTD publishing tools (including docuBridge), MS-Office, Adobe Acrobat applications, electronic document management systems (preferably Generis’ CARA), and the ability to learn required systems and processes quickly.

Knowledge, Skills, And Abilities

• Assesses the impact of document delays on timing of completion of dossier publishing and communicates these impacts to regulatory affairs management and colleagues.
• Advanced editing and formatting skills requiring use of publishing tools, MS Word, pdf editing tools and templates (including StartingPoint).
• Ability to handle multiple tasks simultaneously with strong attention to detail.
• Minimum of two years hands-on experience and knowledge of IND/NDA/CTA/MAA/eCTD applications and ICH/FDA electronic submission requirements and guidelines.
• Ability to work with strict deadlines, changing requirements and changing priorities.
• Excellent interpersonal, communication, and organizational skills.
• Successful performance in a high-intensity work environment.
• Ability to effectively present information and respond to questions internally and externally.
• Knowledge of PC software, including Microsoft Office products.

Pay Range

The pay range for this position at commencement of employment is expected to be between $86,700- $102,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.