Senior Regulatory Writer

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,...

900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals - life scientists, clinicians and project managers across 6 countries and support Novartis in its mission...

Regulatory Writer OpportunityWe are seeking an experienced regulatory writer to join our team.The ideal candidate will have a strong background in scientific/technical writing and editing, as well as experience with complex standard operating procedures (SOPs), guidance documents, and work instructions.Responsibilities include authoring and gaining approval...

Job Title:Regulatory Intelligence Senior ManagerKey Responsibilities:(1) Contribute to the monitoring, analysis, and reporting of global regulatory developments to support timely and compliant product submissions.(2) Deliver high-quality regulatory intelligence outputs such as summaries of country-specific requirements, impact assessments, and...

Job Title: Director Global Regulatory WritingDescriptionWe are seeking a skilled and experienced professional to lead our regulatory writing efforts. The successful candidate will have a strong background in scientific writing, editing, and analysis, as well as excellent leadership and communication skills.ResponsibilitiesPrepare and oversee the review and...

Job DescriptionMajor accountabilities:- To author and review high quality clinical and safety documents: non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP).- 2. Lead for outsourced Narrative projects. Coordinate other outsourced activities in RWS.- 3. Core member of Clinical Trial Team (CTT) /...

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...

Senior Manager, Regulatory Affairs and ComplianceJob Description:The role of Senior Manager, Regulatory Affairs and Compliance involves leading global regulatory strategy with a focus on innovation, ensuring business benefit balanced with regulatory compliance. This includes leading and implementing all global CMC submission activities for assigned...

Data Engineering Manager RoleWe are seeking a seasoned Data Engineering Manager to lead our end-to-end data strategy and execution for regulatory product submissions, lifecycle management, and compliance reporting.This role will be embedded in a cross-functional Regulatory Integrated Product Team (IPT) and serve as the data and technology lead, driving...

Job DescriptionThe Senior Associate, Data Management role involves spearheading key business operation initiatives within Veeva RIM Vault. This ensures alignment with global regulatory requirements, such as IDMP, EU CTR, and other emerging regulations.As a subject matter expert in Veeva RIM Vault, you will collaborate with cross-functional teams to drive...