Global Regulatory Writing Expert

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...

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 Title: Regulatory Writing Specialist\ Job Summary: We are seeking a skilled Regulatory Writing Specialist to join our team. This role involves creating high-quality documents for regulatory submissions, including clinical study reports, observational research study reports, and plain language summaries. The successful candidate will have excellent...

Job Title: Pharmaceutical Regulatory ManagerAbout the RoleThis is an exciting opportunity for a skilled Regulatory Manager to join our team and take on a key role in shaping our pharmaceutical regulatory strategy.The successful candidate will be responsible for formulating and leading global regulatory strategies, ensuring compliance with all relevant...

392687BR **Expert Regulatory Writer**: India **About the role** Position Title: Expert Regulatory Writer About the role: Expert Regulatory Writer Location - Hyderabad #LI Hybrid The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies,...

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...

Medical Regulatory SpecialistAs a Medical Regulatory Specialist, you will play a key role in ensuring the compliance of medical products with regulatory requirements. You will be responsible for developing and maintaining medical expertise within the organization, coordinating activities related to marketing authorizations, and collaborating with...

Job TitleRegulatory CMC Lead SpecialistThis role leads and implements all global CMC submission activities for assigned projects/products. It involves formulating and leading global CMC regulatory strategy, maximizing business benefit balanced with regulatory compliance.Responsibilities:Develop and implement global CMC regulatory strategies to ensure...

We are seeking a Regulatory Change Specialist to interface with global, site, biosimilars, and device regulatory teams. This role is responsible for the global reportability assessment of single or cross-product changes, ensuring that all product-related changes adhere to regulatory requirements.Key ResponsibilitiesChange Assessment: Review change records to...

Job Title: Regulatory Affairs SpecialistAbout the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to achieve business objectives.Key ResponsibilitiesPrepare and review...