Manager - Regulatory Affairs

Medopharm

10 - 20 years

10 - 20 Lacs

chennai

Posted:2 days ago| Platform:

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Skills Required

team handling

Work Mode

Work from Office

Job Type

Full Time

Job Description

Experience in authorizing CMC sections of dossier for drug substance and drug product
Experience in handling applications including regional modules and queries from various health authorities like regulated markets (UK, EU region, Australia Etc.,)
Well versed with eCTD formats of applications, change control and life cycle management
Co-ordination with CROs for arranging BE study for Regulated Markets
Co-ordination with R&D for new product development for Regulated Markets
Co-ordination with plant QA and QC for various regulatory requirements
Interacting with global interdisciplinary project teams to provide strategic regulatory input to development, submission planning, documentation needed, as well as timelines and strategic risks
Supporting and/or preparing high quality dossiers, drug substance and/or drug product quality documentation to support global regulatory submissions (e.g. Clinical Trial Applications, Market Authorization Applications, post-approval variations etc.)
Supporting and/or preparing high quality dossiers according to specific requirements in the different countries and regions
Supporting submission and response activities (planning, preparation, review, coordination, submission)
Ensuring regulatory compliance by creating awareness of requirements and guidelines, facilitating timely submission of variations and participation in the change control process
Supporting the development and maintenance of globally consistent product information

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