My client is actively seeking operations experts to build out their regulatory team. Become part of a dynamic organization offering excellent salary, benefits, and room for professional growth!
The Regulatory Operations Manager will be responsible for ensuring that all regulatory submissions meet the technical document standards consistent with FDA and ICH specifications. This person will maintain an expert understanding of the company's electronic document management system and will also serve as the principal publisher for all U.S. regulatory documents.
- Publish US regulatory submissions to the FDA. These will include ANDAs, Amendments, PADERS, Supplements, Annual Reports, etc.
- Collaborate with document authors to establish and uphold a thorough set of document templates in compliance with FDA and ICH document standards.
- Efficiently monitor all regulatory information, which will include archiving and storing paper and electronic records.
- Supervise all aspects of document progress for various submission types, while ensuring that all functional disciplines maintain timely knowledge of evolving e-submission requirements.
- Write, develop, and/or offer input on SOPs and Work Instructions for the Publishing and Electronic Document Management System.
- Exceptional knowledge of eCTD publishing systems, EDMS technology, and similar publishing tools, as well as proficiency with Microsoft Word, Excel, and PowerPoint.
- Solid background/understanding of CMC regulatory standards and expert familiarity with US FDA e-submission requirements.
- Ability to work independently with extreme attention to detail and administrative, problem-solving skills.
A Bachelor's degree in a life science field is required, as well as at least 7 years in the pharmaceutical industry with a minimum 5 of those years in regulatory affairs. The client would also prefer an advanced degree and a generics background.
Please contact Melissa Riggi at 212-719-7526 or email your CV to firstname.lastname@example.org to be considered for this position!