Skills

• Support Global Regulatory Operations Leads in the coordination, preparation, and submission of all INDS / NDAs / MAAs and life cycle management in eCTD.
• Responsible for the creation, assembly, publishing, and verification of both major and routine regulatory dossier submissions, including IND safety reports, DSUR, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Responses, etc.
• Responsible for maintenance of all Regulatory and Health Authority submission archiving within specified time frames.
• Verification of regulated electronic documents workflows within  electronic document management system.
• Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
• Liaise with functional source areas (clinical, nonclinical, cmc, regulatory) to ensure documents are compliant with authoring style guide.
• Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
• Close interaction with authoring community to track availability of deliverables.
• Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.

Refrences

Worked as a laboratory technician after my pass out and then got oppurtunity to work in a CRO for BA/BE Clinical studies as research associate.

Joined TCS in the year 2009 and have worked on various projects from pre-site initain check , Financial Disclosure activity, Clinical Trial Management and presently working into Regulatory submission Publishing activity

Time and Spatial Flexiblity

Looking for a Job profile in international regions

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