Mylan Laboratories Limited Work Values

Daily Duties at Mylan Laboratories Limited:

•Preparing and reviewing CTD dossiers (eCTD) for generic product submission adhering to the Quality standards and the requirements of the respective Health Agencies. •Uploading the e CTD dossier in Documentum Compliance Manager (DCM) and linking in eCTDXPress. •Ensure timely submission of variations. •Coordinating with colleagues in EU/AUS/NZ/RSA to ensure submission of quality response to regulatory queries on new products submissions / variations, within the time lines of the Health Agencies. •Reviewing regulatory documents (specifications, stability protocols, process validation reports, batch manufacturing records, packaging documents, stability data etc.) required to be submitted to the Health Agencies in support of the new product submission / variations and response to queries. •Reviewing site transfer documents like Product Transfer Document and finalizing the variation strategy to file the site transfer variations. •Reviewing change controls and studying the regulatory impact of the proposed and finalizing the variation strategy. •Reviewing the change controls and giving regulatory comments using TrackWise. •Reviewing documents received from different third party companies against regulatory requirements. •Handling different dosage forms like immediate release tablets, capsules, oro-dispersible tablets and gastro-resistant tablets. •Coordinating with cross-functional departments like R&D, manufacturing, clinical research etc., to ensure the quality and timely new product submission / variations and response to queries. •To keep a track and follow up for the documents required for new product submission / variations and response to queries. •To keep the group updated with the latest regulatory guidelines from different Health Agencies like EMA, TGA and MEDSAFE.

What they like about Mylan Laboratories Limited:

A hiring company that offers alternative approaches to pay, performance bonuses, and/or equity in the firm is very attractive to you. You're generally less interested in working for an organization offering only traditional, salary-based compensation, one with limited opportunity to acquire equity in the firm, or one that does not actively promote skill development. In addition, you are more likely to choose a company that offers a variety of internal career options, with defined career paths. You view the learning of new skills and development of your expertise as key to your career advancement. These aspects of an organization may become even more important to you as you progress in your field, and are especially critical if you change career or occupation.

Tags

Documentum Compliance Manager (DCM), eCTDXPress, ICH, variations, Trackwise, Site transfer, EMEA, TGA, Medsafe, e CTD dossier, NEES dossier, ICH guidlines, change controls, Queries

Skills

ICH guidelines, EMEA, TGA and Medsafe Variation guidelines,, review and preparation Type IA, Type IB, Type II variation, CMN and Category II application as per the Health Agency requirement, Dossier preparation and submissions as per different EU marketing authorizations i.e. National procedures, MRP, DCP; , Nees dossier preparation and review, Trackwise to Trackwise variations review and comment, Trackwise to Trackwise variations review and comment, Site transfer (finished product and API) variations related activities, regulatory compliance, Pharmacoepeial compliance initiatives & people management and document management.

These are some of the questions we asked our climbers about their experiences with Mylan Laboratories Limited: