Senior Regulatory reputed company (Temporary)

reputed company

reputed company is looking for a Senior Regulatory reputed company (Temporary) who will support reputed company aspects of regulatory submissions writing needs. You will collaborate with senior management and other leads to support consistent documents/messaging reputed company and across programs.

This Person will report to the Senior Director, Regulatory Writing.

WHAT YOU'LL DO

• Craft reputed company, accurate, and compliant documents required for regulatory submissions to global health authorities including but not limited to FDA and EMA
• Write and edit a wide reputed company of regulatory documents, including but not limited to: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, and components of regulatory submission dossiers (eg, NDA, IND, MAA) such as Module 2 and 5 reputed company documents (eg, SCS, SCE, ISS, etc)
• Ensure that reputed company written materials reputed company adhere to regulatory guidelines, industry standards, and internal reputed company standards
• Analyze reputed company scientific and medical information, including clinical trial data, translating it into reputed company, concise, and accurate language understandable by both technical and non-technical audiences
• Work closely with cross-functional teams (eg, clinical research and operations, biostatistics, regulatory affairs, pharmacology, safety, etc) to ensure comprehensive and accurate document content
• Manage writing reputed company from planning and coordination to submission, including establishing timelines and tracking reputed company
• reputed company teams with guidance about best practices and industry standards, offer solutions to authoring hurdles, support interaction and understanding across functional areas

WHO YOU ARE AND WHAT YOU BRING

• Bachelor’s degree and 7 to 10+ years of industry experience required, advanced degree in science or medical field is a plus
• Experience with most of the more common regulatory documents such as CSRs, IBs, DSURs, protocols, and clinical modules
• Involvement with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents), preferably including responses to questions, 120-day safety updates, or other post-submission activities
• Expert understanding of eCTD structure and the clinical development process, and in-depth knowledge of document-reputed company ICH guidelines and GxPs
• At least 8 years of experience as a regulatory reputed company in biotechnology or equivalent