Hybrid Senior Regulatory Operations Publisher

at Shionogi Inc. (U.S.)

• Job title: Senior Regulatory Operations Publisher
• Job type: Full Time
• Experience level: Senior
• Salary: $90,000 - $120,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Vault
• Location requirements: Hybrid, Florham Park, United States

About the role

• Senior Publisher preparing and submitting regulatory documents for compliance with FDA and EMA. Collaborating with cross-functional teams and leading regulatory operations initiatives.

Responsibilities

• Lead in the preparation and submittal of regulatory applications and on‐going application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (eg, IND, NDA/BLA, MAA, CTA DMF).
• Participate in project-planning meetings to provide input on submission timelines in collaboration with Manager, Regulatory Operations.
• Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents.
• Conduct final review of published submissions to ensure consistency and compliance with regulatory requirements, as well as ensure metadata is correctly applied.
• Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions.
• Maintain compliance with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and Company procedures and directives while continuing to stay well-informed on future developments.
• Actively participate in the development of Regulatory Operations processes (SOPs/GOPs, work instructions, checklist, templates) for preparing submissions and regulatory information management, in addition to assisting in the creation and maintenance of templates.
• Work with Veeva RIM BA(s), subject matter experts, and cross functional departments to analyze and develop processes that support business needs using the Veeva Vault RIM suite (Submissions and Submissions Archive)
• Develop global partnerships across the organization to help implement Regulatory Operations’ initiatives by attending and participating in Project Teams if deemed appropriate by manager.
• Maintain knowledge of local and global regulatory submission requirements.
• Assist in supporting Regulatory Operations’ technology including, but not limited to publishing tools, databases, and servers.
• Ensure adherence to Company Standard Operating Procedures.
• Mentor and support junior-level team members as needed to help facilitate the team’s growth.
• Perform managerial activities in manager’s absence.

Requirements

• Bachelors’ degree, preferably in a life science or a related field or a minimum of 3-4 years of experience in a small pharmaceutical environment.
• Proven experience in preparing and submitting regulatory documents, including nonclinical, clinical, CMC, DMF, and labeling/SPL., in eCTD format.
• Thorough knowledge and understanding of relevant FDA guidances, ICH guidelines and other regulatory requirements.

Benefits

• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off
• Remote work options