Senior General Manager

Job Title : Senior General Manager - RA (DCGI)

Location : Dholka, Near Ahmedabad, Gujarat

Job Profile :

• 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 the International Marketing Division
• Guidance to the regulatory / quality team to perform their respective functions efficiently and accurately. Identify team member&aposs 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 the 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

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Skills Required

regulatory guidelines