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.
The PharmaBharat Editorial Team, comprised of pharmaceutical industry experts with over 3 years of collective experience in research, regulatory affairs, and market analysis, delivers accurate and timely updates on trends, innovations, and career opportunities. Our content is rigorously vetted by professionals with advanced degrees in pharmacy and biotechnology, ensuring authoritative and trustworthy insights for job seekers in the pharmaceutical sector.
