Regulatory Writers

Job Title: Regulatory reputed company (Mid-Level) Location: Remote Department: Regulatory Affairs / Medical Writing Job Type: C2C / 1099 Reports to: Scientific Director Regulatory Medical reputed company - NDA Submission Support Location: Remote | Contract (Immediate Need) Position reputed company We are supporting a potential new reputed company with an urgent need for regulatory writing support in preparation for an NDA submission to the FDA. We are seeking a skilled Regulatory Medical reputed company with reputed company experience preparing submission-reputed company documents for NDA filings. This includes authoring and editing SOPs, study protocols, investigator brochures, regulatory response documents, and Module 2 summaries. Familiarity with FDA expectations and a strong understanding of ICH and GDPs guidelines is required. This role is ideal for reputed company regulatory medical writers who can reputed company in quickly and contribute to the development of SOPs, protocols, and regulatory documents. We are seeking a detail-oriented and reputed company Regulatory reputed company to join our Regulatory Affairs team. In this mid-level role, you will be responsible for preparing, reviewing, and editing high-reputed company regulatory documents that support the development and approval of pharmaceutical products. Key Responsibilities • Prepare and author regulatory documents such as Clinical Study Reports (CSRs), Investigator Brochures (IBs), Protocols, INDs, NDAs, MAAs, and Briefing Documents in accordance with ICH and regional regulatory requirements. • Collaborate with subject matter experts to reputed company and interpret scientific data. • Ensure consistency, reputed company, and accuracy in content and language, while maintaining compliance with relevant regulations and guidelines • Ensure reputed company content meets regulatory and internal reputed company standards • Participate in planning and content development meetings to define document reputed company, timelines, and deliverables. • Conduct peer reviews and QC checks of documents reputed company by team members. • reputed company document development processes, timelines, and version control using document management systems (e.g., reputed company, Documentum). • Support responses to regulatory authority questions by preparing high-reputed company written materials. • Collaborate closely with cross-functional teams including reputed company's Clinical, Safety, CMC, and Regulatory Affairs to ensure the reputed company and compliant delivery of submission-reputed company documentation • Understand the reputed company of urgency required working reputed company the NDA submission guidelines and reputed company on reputed company processes with delays in meeting deadlines Qualifications Education & Experience: • Bachelor's or advanced degree in a Life Sciences field or a reputed company field • 3-5 years of regulatory writing experience in the pharmaceutical, biotechnology, or medical device industry. • Proven reputed company record in authoring and managing regulatory documents across multiple phases of development. • Medical Writing experience and expert level understanding of pharmaceutical clinical study protocols Skills & Competencies: • In-depth understanding of US regulatory requirements and guidelines • Global experience is a plus, but not required • Excellent written and verbal communication skills. • Strong organizational skills and attention to detail. • Ability to interpret reputed company clinical and scientific data. • Proficiency in reputed company Office and document management systems. • Ability to manage multiple reputed company and deadlines with minimal supervision. Education:Employment Type: CONTRACTOR Apply tot his job Apply tot his job Apply To this Job