Zandra Lifesciences Recriutment 2019- : Zandra Lifesciences Recriutment 2019 for the position of Regulatory Affairs Executive.Please go through following summary of vacancy. Please check at bottom of the this Summary of vacancy for more details and apply on source web page.
|Post Name||Regulatory Affairs Executive|
|Time & Venue||NA|
Opening date: 11/07/2019
Job Description:*Knowledge of ECTD submission, CGMP and Regulatory Guidelines ICH/WHO guidelines Planning, review and submission of Documents as per Country Specific regulatory guideline in medicines/medical devices/nutraceuticals registration Keeping records of documents and samples of different Countries Co-Ordination with respective suppliers/ departments for Regulatory requirements such as documents (Quality Analysis report, Comparative study report, Validation protocols and Reports, New product Documents, Legal documents, Samples and Reference Standards etc.) Artwork checking and development Clinical Evaluation, Literature Search, Risk Management, Post Marketing Surveillance Responsible for resolving product registration queries as per requirement Should be able to get involved in External & Internal Audits conducted by various notified bodies & specific country FDA Responsible to guide the organization with the new regulatory guidelines and provide the updated knowledge relevant to regulatory guidelines of respective countries Review technical documents like process validation, AMV, Stability and composition etc, labelling, batch records, specification sheets or test methods for compliance with applicable regulations and policies Skills Required: Excellent communication Liaison skills Diligence in execution and follow through with a ‘can-do’ attitude. Teamwork Ready to perform Multi-Tasking
About Company : Zandra in Spanish means “defender of mankind”. Our mission is defending mankind from disease and making sure you live and cherish every moment of your life. At Zandra Life Sciences, it is our constant endeavour to combine cutting edge innovation with extensively researched products.