Regulatory Affairs - Ops Manager
San Diego Metro Area, California
- The Regulatory Operations Manager is the technical leader for electronic submissions who supports the Company across multiple functions with a focus on the systems specific to regulatory submissions and reporting.
- BS or MS with 5+ years of direct experience in a Regulatory Operations function with experience with electronic submissions and systems.
Demonstrated technical leadership in the successful submissions to regulatory agencies of: INDs in e-CTD format, IMPDs, CTAs, NDA, MAAs, BLA/Supplements, Periodic Safety Update Reports, etc.
Demonstrated track-record in managing regulatory timelines and coordination of publishing calendar associated with the assigned submission, including initial quality control of submissions.
Relevant working experience (with respect to Regulatory Operations needs) with the FDA, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) or equivalent experience with similar regulatory authorities e.g. EMA
Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: Adobe, XML and SML authoring tools, eCTD Software, SAS file formats.
- A successful candidate is expected to work closely with regulatory affairs colleagues, contract electronic publishing service providers, members of the research, development, manufacturing, quality assurance, non-clinical and clinical functional areas, and to represent Regulatory perspectives in discussions regarding regulatory operations. Specifically, the candidate will provide ongoing formatting, templates, organizational advice and guidance for optimal submissions, and ensure quality control and timely preparation of submissions.
- A key expectation of the candidate is that he/she maintains current knowledge of regulations and FDA and European guidance documents with respect to electronic submissions, and provides expert advice to project teams and the department.
Supervises and/or participates in the gathering of information and the assembly of regulatory submissions for Company s development- and commercial-stage products
Oversees the preparation and completion of regulatory submissions, including INDs, CTAs, NDAs, BLAs, safety reports, annual reports and routine amendments in eCTD format
Ensures that all aspects of electronic submissions and documents meet regulatory agency and Company s submission standards and technical requirements
Establishes and maintains effective working relationship with electronic submissions vendors
Interacts with regulatory authorities for Regulatory Operations inquiries; assists in establishing departmental standards to ensure the highest quality of submitted information
Provides publishing project plans and timelines for major regulatory publishing projects
Provides technical leadership regarding the life cycle management of electronic submissions
Adheres to Company s policies and supports management decisions and goals
Stays abreast of new technology
Assists with the training of submission activities to all levels of Regulatory operations staff
Ability to QC documents for electronic submission.