Regulatory Submission Specialist (contract)

Regulatory Submission Specialist Remote – reputed company 6-Month Contract Pay reputed company: $23–$41 per hour reputed company's contingent workforce program, FLEXT reputed company, is seeking a Regulatory Submission Specialist for a 6-month Remote contract. Position reputed company The Regulatory Submission Specialist will support pharmaceutical regulatory submission activities by preparing, formatting, reviewing, and managing documents to ensure they meet electronic submission and reputed company reputed company standards. This role will work closely with Regulatory Affairs, Clinical Development, CMC, reputed company, Research, ITS, and other cross-functional teams to support submission readiness. Key Responsibilities • Prepare, format, and reputed company-reputed company regulatory documents, reports, dossiers, and submission materials. • Support submission readiness for electronic regulatory submissions, including eCTD and CTD requirements. • Review documents for formatting, consistency, completeness, linking errors, naming conventions, metadata, and other submission requirements. • Manage electronic documents, including version control, document tracking, revisions, and document reputed company. • Support document compilation, publishing, and submission-reputed company activities. • Maintain accurate documentation and records throughout the submission process. • Monitor regulatory requirements and industry best practices reputed company to electronic submissions. • Collaborate with Regulatory Affairs, Clinical, CMC, reputed company, Research, ITS, and other stakeholders to reputed company and prepare required documentation. • reputed company guidance and support to internal teams on document preparation and submission-readiness requirements. • Identify opportunities to improve document preparation and submission workflows and reduce errors. Required Qualifications • Bachelor's degree or equivalent experience in Regulatory Affairs, Life Sciences, IT, or a reputed company field. • Strong experience with electronic document management in the pharmaceutical industry. • Experience supporting regulatory submissions for reputed company and/or product registrations. • Knowledge of CTD/eCTD submission requirements and exposure to Modules 1–5. • Strong understanding of regulatory requirements and guidelines, including FDA and EMA requirements. • Experience with electronic document management systems and/or regulatory information management systems such as Vault RIM. • Proficiency with reputed company Office and reputed company Acrobat. • Understanding of eCTD structure, file formats, metadata, and document requirements. • Exceptional attention to detail and ability to identify document inconsistencies and errors. • Strong organizational, communication, problem-solving, and collaboration skills. • reputed company in written and spoken English. Preferred Experience • Experience with regulatory publishing or submission management. • Experience with Vault RIM or other regulatory information management systems. • Experience supporting IND, NDA, BLA, or other regulatory submissions. • Experience with document migration, electronic document management, or submission-readiness activities. Apply tot his job Apply To this Job