Prepares (e.g.: compile, organize, assembly, and transcribe) applicable information and data for IND and/or NDA applications, Amendments, Supplements, Safety Reports, Annual Reports, Agency meeting/briefing documents and general correspondence for all assigned clinical development and/or marketed products for submission to regulatory agencies.
• Provides guidance and support for organization, formatting, and structure of assigned regulatory submissions (IND, NDA) for assigned products and/or therapeutic area(s).
• Manages the internal submissions process:
• Tracks and monitors all submissions in-progress
• Identifies/anticipates roadblocks and helps identify solutions to support the scheduling and timelines of major regulatory submissions.
• Acts as contact for collection of required documents from participating departments,
and distribution of those documents for review and approval by Regulatory Affairs management.
• Provides regulatory support to other departments and multi-functional teams to ensure compliance with regulatory requirements for content and format of paper/electronic regulatory submissions and documentation.
• Ensures the accuracy and completeness of electronic and hard copy regulatory files.
• Provides support during interactions with regulatory agencies reviewing submission content.
• Coordinates and prepares SPL submissions as required.
• Contributes to process improvement initiatives across the organization.
Assists with other regulatory activities and special projects as required.
Minimum BA/BS or equivalent work experience in life science or closely related field.
Minimum of five (5) years overall experience in the pharmaceutical industry.
Minimum of three (3) years direct experience with regulatory submissions.
Knowledge and Skills:
Proven project management skills; ability to multi-task, meet deadlines as well as coach colleagues to meet deadlines
Working knowledge of computer software, including advanced MS Word features.
Experience with publishing tools and electronic document management systems as used within the pharmaceutical industry.
Strong problem solving skills. Ability to manage tasks with clear objectives/goals, measures, process, progress, and results with attention to detail.
Strong interpersonal, communication and influencing skills and ability to collaborate effectively with other groups in a matrix organization.