DRA

Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.

Compilation and review of product license applications, variations, and renewals for Mexico or ASEAN countries as per regulatory requirements respectively with minimal supervision. Manages electronic documents and creates electronic submissions in CTD format.

Knowledge of FDA, cGMP, ICH, DMF guidelines for regulatory submissions. Hands on experience in CMC submissions, supplemental applications. Experience working on labels will have added advantage. Excellent written and verbal communication skills; experience in Regulatory Affairs of Finished dosage formulations mainly for USFDA, EU. M Pharmacy / M. Sc. / B Pharm

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.