Manager, Regulatory Publishing

Overview

Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in  Neurology in Parkinson’s (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology.

MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets.  In the United States, MTPA launched rare disease treatments including RADICAVA® (edaravone) injectables in 2017 and RADICAVA® (edaravone) oral suspension in 2022.  The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions.  MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.   

The Manager, Regulatory Publishing will publish regulatory submissions (Initial Applications, Amendments, Supplements, Safety Reports, Annual Reports, Agency meeting/briefing documents and general correspondence), ensuring timely submission of high quality, compliant and valid submissions in eCTD format to the FDA and Health Canada within required timeframes.

Responsibilities

• As the lead publisher of assigned compound(s), manages complex and routine eCTD publishing activities from initial IND/NDA through lifecycle.
• Formats submission documentation for eCTD compliance.
• Creates submission application in docuBridge, publishes submission contents as fully compliant, validated electronic submissions.
• Contributes to new and updated processes and standards.
• Participates in validation testing of new and upgraded software.
• Monitors new and updates to regulatory policies and guidance relating to electronic submissions from various regulatory authorities and other applicable agencies and/or professional organizations.
• Ensures quality control (QC) of all documents.
• Maintains all applicable regulatory files, and source documents used to create filings for assigned investigational and/or marketed products.
• Maintains an advanced working knowledge of FDA regulatory guidance and policies.
• Assists with the development of best practices that conform to regulatory requirements for eCTD publishing.
• As applicable, provides expertise to project teams on the application of electronic submission requirements for specific submissions.
• Maintains working knowledge of global and local electronic submission guidelines.
• Contributes to process improvement initiatives across the organization.
• Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process.
• Assists with other regulatory activities as required.

Qualifications

• Minimum BA/BS or equivalent work experience in life sciences, computer science or related field.
• Minimum of 3-5 years relevant work experience with strong background in the pharmaceutical industry in a reporting or compliance-related function.
• Experience with CDER and/or IND, BLA, NDA regulatory submissions.
• Advanced experience with eCTD publishing tools, preferably docuBridge, ISI Toolbox and Documentum.
• Advanced experience with electronic document management systems.
• Advanced knowledge of FDA regulatory guidance and policies regarding eCTD submissions.
• Proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook), Adobe Acrobat and Documentum.
• Strong communication (written and verbal) skills; communicates and collaborates effectively with internal colleagues and external service providers and suppliers.
• Detail-oriented, organized, quality driven and able to work in a team environment under tight deadlines.

Our Value Proposition:

Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate.  At this time, Mitsubishi Tanabe Pharma Ame