Regulatory affairs

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.

Coordinating with cross-functional teams for data collection and dossier preparation. Handling regulatory queries and responses from global health authorities. Ensuring compliance with ICH guidelines, USFDA, EDQM, and other international regulatory standards

Evaluation and submission of application on online portal for getting domestic manufacturing and marketing permission from DCGI. Evaluation and submission of applications on online portal for import registration, import license of drugs and medical devices in India. 

The ideal candidate will be responsible for compiling Drug Master Files DMFs and Certificates of Suitability CEPs, ensuring compliance with global market regulations and emerging market standards in accordance with ICF guidelines. This role requires strong coordination with internal stakeholders and expertise in regulatory submissions, amendments, and annual reports.

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

Experience in regulatory strategy, dossier review, and submission for the US, EU, and Brazil markets. This role requires a deep understanding of CMC requirements and the ability to lead the regulatory strategy for various dosage forms, including complex injectables and ophthalmic products.

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.

Preparation and submission of post approval variations and send proper communication for implementation of the change. Co-ordination with GRA, Country regulatory affiliates and COE for submission of dossier and supporting the required documentations.