Exe (Regulatory Affairs)

Sun Pharma · Vadodara, Gujarat · Posted 2 days ago

About this role

Job Title Regulatory and Business Continuity Business Unit R&D1 Regulatory Affairs Job Grade G12A Executive Location : Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job Description • Review all data and documents related to product registrations for various health authorities. • Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel. • Prepare responses to deficiency letters received from various agencies. • Maintain life-cycle / post approval changes for drug product registration dossiers. • Provide regulatory support to cross functional departments. • Prepare and submit scientific advice to various health authorities. • eCTD compilation, verification and submission through electronic gateway • Review, preparation and submission of annual reports to US FDA • Review, preparation and submission of post approval supplements to US FDA • Reviewing of the plant change control and established the var