DRA

Provide technical inputs on review of CMC data for Central CDSCO and State dossiers related to new products under development Liaison with other departments such as l&D, Quality, Supply chain, Project Management, etc to deliver high quality dossiers, in accordance with business priorities

Preparation of regulatory monitor and market intelligence data. Analyse and share market intelligence data and preparation of regulatory monitor capturing key regulatory developments on monthly basis.

Sets up product development and registration objectives in aligment with RA Sub-Region Head, RA MOW Head New Product Planning, Regional Commercial team objectives and in close partnership with the local LT. Master in Life Sciences degree. PhD or Higher Degree or equivalent experience desirable

interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. Lead submission for annual reports, facility registrations, facility renewals, and product renewals. Interact with authors, reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions.

Syngene is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

As part of the Infosys consulting team, your primary role would be to get to the heart of customer issues, diagnose problem areas, design innovative solutions and facilitate deployment resulting in client delight.

Plan and coordinate with various departments like QA, QC and Production, to project the document requirements for appropriate submissions. Co-ordination with clients for the tracking and status update of project plans.

Author Safety Data Sheets for multiple geographies across the globe as per applicable hazard communication regulations. Derive hazard classifications for substances and mixtures using various classification regulations including but not limited to GHS, CLP, and OSHA Hazard Communication Standard.

B.Pharmacy, M. Pharm, Bsc or MSc; Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time