Deputy Manager

1. Dossier & query submission and its life cycle management for China

market and other emerging markets based on regulatory planner.

2. Fortnight/monthly telecom with country partner regarding clarifications

& updates.

3. Experience in preparation of Regulatory Strategy for product development

for China & other emerging markets.

4. Guidance to manufacturing units for technical data generation &

documents review wrt China & global regulatory requirements.

5. Facilitation for filing of cGMP, site registration applications, GMP

inspection, Timely CAPA submissions, approval & its maintenance for

other emerging markets

6. Support in projects allotted by team-leader/HOD based on

urgency/requirement of the company on need basis

Other Skills required

1. Academic Qualification: M. Pharma in Pharmaceuticaal analysis /

Pharmaceutical Chemistry/Pharmaceutics/Quality Assurance/Regulatory

Affairs

2. Technical Experience : 6-10 years in China & other emerging markets.

3. Behavioural Qualities : Good attitude, self-motivated, enthusiastic, good

communication skills, able to drive the projects aggressively & timely, project

management & time management skills, working with high level of

commitment, good analytical thinking & eye for detail, team player & good

inter-personal skills.