Regulatory Writing Specialist

Regulatory Writing Manager Job DescriptionThis role involves overseeing the creation and approval of regulatory documents, ensuring compliance with applicable standard operating procedures. The successful candidate will have significant experience in scientific/technical writing and editing, as well as a strong understanding of clinical development...

Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team. In this role, you will be responsible for maintaining close cooperation with regulatory authorities to discuss requirements, strategies, and knowledge of global product dossiers to stay up-to-date.Maintain close cooperation with regulatory...

Regulatory Writing Manager Job Description:Job Summary:We are seeking an experienced Regulatory Writing Manager to lead the development and submission of regulatory documents. The successful candidate will have a strong background in scientific and technical writing, as well as excellent leadership skills.Key Responsibilities:

Job DescriptionIt is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.- Prepare and oversee the review and approval of...

Job DescriptionRoles & Responsibilities:- Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric...

Career Category RegulatoryRoles and Responsibilities Performs document-level QC including abbreviations references to sources data in text versus data in tables figures or graphs etc to ensure submission readiness quality Ensures the consistency and accuracy of layouts fonts margins styles and spacing logical content organization and proper...

Job DescriptionAs a regulatory compliance specialist, you will be responsible for ensuring our products meet the necessary regulatory requirements. This involves product data mining from regulatory data tools, engaging with IT to backfill product data into ERP systems, and providing customer support on regulatory document requests.You will also be involved...

Regulatory Affairs Specialist">We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory group, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the approval of our products.">Lead submission for annual reports, facility registrations, facility renewals,...

Job DescriptionRoles and Responsibilities- Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) to ensure submission readiness quality- Ensures theconsistencyandaccuracyof layouts, fonts, margins, styles, and spacing, logical content organization, and proper use of headings,...

Job DescriptionIn this vital role, you will author and gain approval of scientific and regulatory submission documents that align with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision)...