Sr. Regulatory Publishing Specialist
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About The Position
The Senior Regulatory Publishing Specialist will be an integral part of the Regulatory Operations team within the Regulatory Affairs function for Specialty Generics at Mallinckrodt Pharmaceuticals. This role is pivotal in coordinating the publishing process to ensure that submissions to the FDA and other regulatory agencies are both timely and accurate. The specialist will be responsible for assembling and publishing US FDA eCTD submissions as well as other submission types for global applications, ensuring compliance with established guidelines and regulations. In this position, the specialist will coordinate publishing efforts for submissions to the FDA and other global health authorities. This includes generating drafts and assembling submissions using established templates while ensuring eCTD compliance per FDA guidelines. The role requires a thorough review of the format of published outputs and managing documents within the Veeva and Insight suite. Additionally, the specialist will generate XML Backbone for electronic submissions and maintain up-to-date records of completed submissions and those in progress, ensuring that applications are current in Regulatory Viewing software. The Senior Regulatory Publishing Specialist will also assess the impact of regulatory changes on current work procedures and standard operating procedures (SOPs), as well as the impact of software updates. Anticipating regulatory consequences of changes in application formats is crucial, and the specialist must ensure that all documentation, both received and generated, is accurate. The role involves assisting members of the Regulatory Affairs department in interpreting FDA and ICH guidance as it relates to established CTD/eCTD templates and various other submission types, including NDA, ANDA, IND, DMF, PSUR, Annual Reports, and Pre-Meeting Packages. Furthermore, the specialist will enforce the use of appropriate request processes and respond to user requests in a timely manner. Maintaining knowledge of current regional regulations regarding application formats is essential. The role also includes attending department meetings, closely interacting with department members, and representing the Regulatory Operations group on projects related to software updates and submission formats. Mentoring and training new hires and junior members of the Regulatory Operations group is also a key responsibility, along with other duties as assigned, with or without accommodation.
