:

• Liaison with regulatory authorities/government bodies, coordination with customers/consultants - DGCI and India Regulatory bodies • Provide regulatory advice to cross functional departments right from the development stage leading to a scientifically sound regulatory submission within committed project timelines • Provide regulatory inputs and frame up strategy of regulatory submission during business development discussions with international customers and International Marketing Division • Guidance to regulatory/quality team to perform their respective functions efficiently and accurately. Identify team member's capabilities to perform and assign additional responsibilities accordingly. Adopt the role of a mentor to team members both personally and professionally.





- Facilitate in preparing compliance to GMP audit observations for own facilities • Guide cross functional departments on implementation of systems for regulatory expectations and compliance • Review of technical and investigation reports, summaries for adherence to regulatory guidelines and to provide guidance to cross functional technical teams for the requirement and content of regulatory documentation • Evaluation of Day to Day operational issues w.r.t regulatory implications and providing short term and long term mitigation measures

📌 Senior Vice President (India)
🏢 DigiCAD
📍 India