Description

This role is responsible for the day-to-day support and document management of Regulatory correspondence, submissions to Global Regulatory Health Authorities, and Quality documents. This includes ensuring that all Regulatory and Quality documentation transferred from CROs are complete and archived into Veeva document management system in a timely manner. This role reporting into the Sr. Mgr., Regulatory Affairs Operations.

Responsibilities

• Supports Regulatory archive activities as needed including migration and archiving of all Health Authority communications received from global health authorities, submissions and quality documents either directly or indirectly from CROs
• Provides support and training on company best practices and industry standards for document management of Regulatory and quality documents
• Contributes toward the development and implementation of department-wide SOPs, policies and/or work processes to streamline all submission activities and standardize interactions with other departments
• Supports US and ex-US submission activity, including (but not limited to) the preparation, formatting, and QC of documents being submitted to health agencies.
• Review and format document according to company and industry standards
• Troubleshoot and resolve complex document formatting or document processing issues
• Gather information in support regulatory submissions for drugs products
• Plays an integral role in the QC of Regulatory Documents and Submissions.
• Assists in typing, formatting, editing, proofing, creating and manipulating complex tables, converting text and graphics, scanning, bookmarking and hyper-linking.
• Maintain regulatory submission timelines, formatting & publishing documents for submission to FDA and other global regulatory agencies, assembling and building Regulatory eCTD submissions such as original INDs, IND amendments and/or CTAs
• Supports daily submission activity, including (but not limited to) the assembly of Regulatory Submissions to US FDA in both paper and electronic eCTD format.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.

• Bachelor's degree and/or equivalent work experience
• 5 or more years of pharmaceutical industry experience
• Proficient with eCTD publishing software preferred (e.g. OmniFILE, DocuBridge, GlobalSubmit PUBLISH, or Veeva Publishing)
• Working knowledge of eCTD authoring templates (e.g. StartingPoint, TransCelerate) and Acrobat publishing plug-ins (e.g. ToolBox Pharma, AutoPageX)
• Familiarity with eCTD structure and FDA Comprehensive Table of Headings and Hierarchy, follows and interprets FDA, EMEA and ICH guidelines for electronic submissions
• 5 or more years in Regulatory Affairs Operations, with demonstrated ability to interact successfully with team members
• 4 or more years working in Veeva RIM
• Expert in Microsoft Office (MS Word and Excel)
• Proficient with Adobe Acrobat
• Familiarity with FDA requirements for regulatory submissions (such as eCTD)
• Outstanding interpersonal, planning and organizational skills
• Have a passion for quality and an impeccable detail orientation
• Excellent writing and verbal communication skills
• Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $110,000 - $120,000. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.