About Intercept Pharmaceuticals
Intercept Pharmaceuticals, Inc. is an American biopharmaceutical company incorporated in 2002, focusing on the development of novel synthetic bile acid analogs to treat chronic liver diseases, such as primary biliary cirrhosis (PBC) now called primary biliary cholangitis, non-alcoholic fatty liver disease (or non-alcoholic steatohepatitis, NASH), cirrhosis, portal hypertension, primary sclerosing cholangitis and also the intestinal disorder, bile acid diarrhea.
About the role
Elevate your career by joining the world's growth industry. Thrive in an setting that fosters positive relationships and recognizes outstanding performance We know you want to feel valued every single day and be recognized for your contribution. At Intercept Pharma, we strive to empower our employees and effectively engage your involvement in our success.
Responsibilities
To review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations,



Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements.
To review outsourced intermediates for regulatory adequacy to support Procurement Team in vendor selection.
To coordinate with Chemical Research Department, Analytical Department and Manufacturing locations in generating data as per the requirements of regulatory agencies.
To ensure reposition of API dossiers into central repository and to provide information about regulatory commitments in timely manner.
Demonstrates positive R programming skills
Can participate in development of recent standard CM functionalities. Tasks can involve gathering of requirements, programming, testing and documentation.
Can design, develop and lead development of study specific CM analyses. Tasks can involve gathering of requirements, programming, testing, documentation, coordination of work o

📌 Data Analyst Bengaluru
🏢 Intercept Pharmaceuticals
📍 Bengaluru