CRMROM

MANAGER, REGULATORY OPERATIONS Summary of Responsibilities

 

Reporting to the Director, Regulatory Affairs, the Manager, Regulatory Operations oversees the production, management, archiving, and indexing of regulatory submissions, in both electronic and hard-copy formats, for R&D projects and commercial products. 

 Specific Responsibilities

 

· Schedule, manage, and set priorities for the compilation, publishing, distribution, and archiving of regulatory (IND/NDA) submissions and regulatory communications (incoming and outgoing)

· Manage the maintenance of and access to the official corporate regulatory archives; ensure that all archived documents are maintained in a manner that will support FDA on-site inspections and due-diligence activities

· Interface with, manage, and set priorities for the RA documentation activities of contract research organizations contracted to compile and publish major electronic and paper regulatory submissions and/or to provide components of these documents

· Establish, update, implement, and provide training on RA Operations formats, templates, policies, standards, and procedures for regulatory documentation

· Represent RA Operations in submissions planning meetings of project teams and advise the teams on the timelines and process for regulatory submissions publishing; prepare and maintain submission tracking documents and monitor status of submission components

· Review and provide advice on the structure and preparation of regulatory submissions

· Evaluate and recommend the implementation of electronic document management and publishing media for the production and archiving of electronic submissions; manage the regulatory use of these systems

· Maintain up-to-date knowledge of FDA standards and procedures for regulatory submissions, including eCTD and PLR/SPL; analyze new and revised guidance, advise Regulatory management of new requirements, and recommend course of action

· Plan and implement on-site storage space solutions for regulatory archives, in conjunction with Facilities group

· Evaluate the facilities and services of vendors contracted to provide permanent off-site document storage, and manage the transfer and retrieval of RA documents stored off-site

· Manage, train, and evaluate Regulatory Documentation Assistants, Coordinators, and Specialists

 

Qualified candidates please send current resume to:  Careers@professionalplacementpartners.com .