Job Responsibilities:
- Prepare and/or review regulatory submission documents to support clinical trial and marketing authorization activities for internal and/or external clients.
- Provide regulatory support for assigned projects.
- Responsible for the creation, assembly, and publishing of global paper and electronic submissions, including NDAs, INDs, 510(k)s, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, and Renewals.
- Support Regulatory Affairs personnel in the coordination, preparation, and submission of all submissions.
- Pre-publishing (Bookmarks and Hyperlinks), compilation, post-publishing, and validation of regulatory submissions and lifecycle management submissions.
- Identify project needs, track project timelines, implement client requests, and manage day-to-day workload in collaboration with senior staff.
- Perform QC processes to ensure the integrity and quality of each published unit.
- Plan, prepare, track, and archive regulatory documents and submissions in paper and electronic formats.
- Maintain all regulatory and FDA correspondence, ensuring timely distribution and filing into the electronic document management system.
- Liaise with functional source areas (clinical, nonclinical, CMC, regulatory) to ensure documents are compliant with authoring style guides and regulatory/company guidance/template specifications.
- Actively participate in project teams with internal and external customers and communicate confidently on straightforward matters.
- Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the US FDA, EMEA, and ICH.
- Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
- Interact closely with the authoring community to track the availability of deliverables.
- Technical knowledge of electronic publishing systems and software (RIM Smart, Insight, eCTDXpress, Extedo, Lorenz).
- Prepare and deliver training, as appropriate.
- Proficiency with MS-Office Suite and Adobe Acrobat applications, knowledge of Electronic Document Management Systems.
- Solve day-to-day queries of team members.
- Self-starter with superior time management skills and the ability to work independently or in teams.
- Perform other tasks or assignments as delegated by Regulatory management.
