Regulatory Operations Specialist IV

Regulatory Operations Specialist IV

Irvine, CA

 

Overall Purpose:

Work with regulatory document authors to achieve resolution and ensure that regulatory documents comply with regulatory and company guidance/template specifications this will include working with Medical Writing, Quality Assurance and Clinical Research departments to implement quality control checks which ensure all information provided in the context of regulatory submissions is accurate, complete and meets regulatory document specifications.Project manager: implement and validate regulatory publishing systems for the company.  This includes working with IT and the vendor to manage the validation of systems.  Responsible for the creation and compilation of quality global Regulatory submissions and lifecycle management submissions.  This includes facilitating the development of electronic systems and planning, preparing, tracking, and archiving regulatory documents and submissions in paper and electronic formats.

 

Duties & Responsibilities:Ensure process for submission of regulatory document is performed in accordance with established procedures.Evaluate, implement, and manage updates of regulatory publishing systems for the company, this includes working with IT to manage the validation of systems.  This includes coordinating the migration of CMC, non-clinical and clinical documents into submission ready documents.Plan and prepare regulatory submissions to FDA and other regulatory agencies using paper and/or electronic publishing tools.  This includes, executing the daily activities involved with the preparation, QA and assembly processes involved with submissions.Manage official regulatory files in paper and electronic form.  This includes receiving and organizing component documents from paper and/or electronic sources.Support various task force activities related to new applications and supplements.Creates and maintain tracking systems for component pieces of submissions.Ensure conformance with regulatory requirements, guidelines, internal standards and timelines.Establish and implement processes for departmental SOPs as well as the generation of electronic submission-ready documents.  This includes developing training materials, providing training and technical/document support to internal disciplines and external contractors.Liaise with external vendors in support of regulatory submissions.Maintain the Regulatory Archive Database layout updates, changes and upgrades.Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the FDA and ICH.

 Physical Demands and Work Environment

 

The physical demand described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Qualified Requirements:

Education & ExperienceBachelor?s Degree or demonstrated industry experience5-10 years pharmaceutical industry experienceKnowledge of IND, NDA, MAA, CTD requirements and guidelinesProficiency with MS-Office Suite and Adobe Acrobat applications

Knowledge & AbilitiesStrong technical knowledge of electronic publishing systems and softwareSuperior Organizational skillsdetail-orientedexperience with regulatory documentation (either authoring, review, QC or audit)a well-developed understanding of quality standards for regulatory documentsexcellent verbal, written and interpersonal skillsexperience in working effectively in cross-functional teamsAbility to work under strict deadlines and changing priorities with minimal supervision on routine assignmentsSelf-starter, able to work independently or in teamsAbility to effectively manage resources to achieve business objectives