Senior Regulatory Operations Associate

Description

The Senior Regulatory Operations Associate will be responsible for functional activities related to US and global regulatory submissions as well as clinical and compliance documentation.

 Responsibilities:

• Support submission activities associated with generating electronic submissions
• Responsible for compiling and coordinating submission activities, including MS Word document formatting, converting documents to PDF in compliance with the FDA guidelines, and scanning documents (Electronic publishing is currently done by our vendor.)
• Maintain proficiency and expertise with the tools and processes associated with electronic regulatory submissions (e.g., Toolbox, Acrobat Pro)
• Contribute to submission planning in order to identify pending submissions and to define priorities
• Anticipate upcoming tasks based on the timeline of submission filing dates
• Perform quality control checks and coordinate fixes with publishers:
  • Regulatory source documents generated by Regulatory Affairs, Clinical, and Non‑clinical departments to ensure compliance with relevant content and format guidelines
  • Published PDF output files
• Support authors to complete regulatory documents such that all components are provided and presented in the correct format
• Assist and/or train others on tools used to support publishing efforts
• Maintain Regulatory Affairs on-site and off-site archive storage (paper and electronic)
• Assists with other projects to support the regulatory departments as assigned

Qualifications:

• BA/BS degree in life sciences or a related discipline
• Minimum of three years of direct experience in a Regulatory Operations function, including experience with electronic submissions and the publishing processes
• A minimum of three years of related experience in the pharmaceutical/biotech industry and/or a combination of experience and education/training
• Working knowledge of FDA electronic submission regulations
• Software proficiency: Windows, MS Office (Outlook, Word, PowerPoint, MS Excel), Endnote, SharePoint authoring templates, Adobe Acrobat, and Toolbox.
• Working knowledge of other software required: eCTD viewing and validation software (Rosetta Phoenix), electronic publishing, , SharePoint (QUMAS), ACUTA ARIM, Veeva Vault.
• Very detail oriented; well organized; quick learner
• Experience with formatting Word documents against a corporate style guide a plus
• Strong written and verbal communication skills
• Ability to multitask and prioritize when working on multiple projects, and deliver on tight timelines within a fast-paced team environment; resourceful, service oriented and an effective team player
• Flexible in handling changing priorities
• Effective/productive working with minimal supervision