Global Regulatory Submission Manager

Job Description Summary

-Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.

 

Job Description

Key Responsibilities

• Drives cross-functional teams focused on the planning, compilation and dispatch of worldwide regulatory submissions, anticipating technical obstacles and developing solutions. Manages multiple and simultaneous global regulatory submission projects in eCTD and non-eCTD format [e.g., NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA AtoQ, Compliance submissions, etc.].
• Provides guidance to project teams related to worldwide HA submission structure/format/requirements, submission filing strategy, eCTD document lifecycle management and submission compilation workflows.
• Tracks timely delivery of submission components, coordinates submission publishing activities with publishing team and organizes internal review and approvals.
• Partners with cross functional groups across the organization and contributes to operational activities and ongoing initiatives.
• Effectively troubleshoots technical/quality issues relating to compilation, validation and dispatch of global submission outputs.
• Assesses publishing resource and support needs and develops/implements solutions to create efficiencies.

Minimum Requirements:
• 3-5 years of Regulatory Affairs or Regulatory submission related experience. BS in Life Sciences or a relevant discipline with at least 5 years of professional work experience. Master's degree preferred
• Experience with global regulatory submission formats, including familiarity with submission publishing activities. Familiar with the drug development process.
• Effective interpersonal skills, strong written and oral communication and presentation skills.
• Solid project management, organizational and time management skills to manage multiple ongoing projects simultaneously.
• Familiar with global Health Authority regulations/guidance eg., FDA regulations, ICH and EMA guidelines/directives.
• Works independently and with minimal supervision.
• Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly

 

Skills Desired

Data Analysis, Documentation Management, Lifesciences, Regulatory Compliance, Waterfall Model