Global Regulatory Writing Manager

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 Overview:The position of Global Regulatory Writing Manager is a leadership role that oversees the development and submission of regulatory documents. This includes Clinical Study Reports, Investigator Brochures, and other critical documents.This key leader will guide a team of writers to ensure timely completion of high-quality documents. A strong...

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)...

Key AccountabilitiesAs a seasoned regulatory professional, your primary responsibilities will involve developing and implementing global regulatory strategies to ensure timely submissions and approvals. You will collaborate closely with regional teams to align on regulatory approaches and facilitate the submission of dossiers worldwide.Main...

Job DescriptionMajor accountabilities:- Is responsible for implementing regulatory strategy and managing operational activities for assigned medium regions.- Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic...

Regulatory Compliance SpecialistA key role that demands expertise in regulatory affairs and the ability to manage global CMC submission activities with strategic oversight.Key Responsibilities:Develop, implement, and maintain global CMC regulatory strategies that align with business objectives while ensuring compliance with regulatory requirements.Oversee...

Job OpportunityTo ensure effective documentation systems, we are looking for a professional to oversee record retention and information services. This includes managing electronic records in line with regulatory requirements.Main ResponsibilitiesManage medium to small global submission projects with regulatory bodiesProvide submissions and contribute to the...

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 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 DescriptionMajor accountabilities:- Is responsible for implementing regulatory strategy and managing operational activities for assigned medium regions.- Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic...