Job Description:

• 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 (Bhat)
🏢 DigiCAD
📍 Bhat