Regulatory Affairs-US, EU-Formulation

Job Description

Responsible for the end-to-end publishing of regulatory submission documents for global markets (US, EU, Canada, APAC, GCC, Switzerland). Manage eCTD structure creation from M1 to M5 modules using Insight Publisher, assign documents from DocNet repository, and perform global regulatory submissions. Ensure documents meet ICH guidelines and regional health authority requirements, including accurate formatting, PDF creation, bookmarking, hyperlink activation, font embedding, and searchable text. Perform detailed quality control checks on pre-published M1-M5 documents, ensuring compliance and consistency for regulatory submission readiness. Work closely with medical writers, submission leads, and cross-functional teams to compile and format regulatory documents (e.g., CSRs, CSPs, IBs, SAPs, CRFs, amendments, manuscripts, etc.). Provide guidance and mentorship to junior team members on document preparation, publishing processes, and technical solutions. Handle publishing tasks for submissions to global regulatory agencies and ensure that documents are submission-ready across multiple regions. Address technical issues related to documents and applications, providing solutions to ensure smooth publishing processes. Comply with company SOPs and contribute to the development and implementation of new SOPs related to publishing and regulatory submissions. Keep up-to-date with regulatory trends, medical writing, and drug development advancements to ensure that submissions align with the latest industry standards. Manage day-to-day workload for assigned tasks, ensuring deadlines are met and high-quality standards are maintained. Handle publishing activities for various global regions, ensuring submission documents are in the appropriate format and meet the technical requirements for each market.