Senior General Manager

Job Title

Location

Job Profile:

DGCI

•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'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 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