Job Description:

Purpose of the position:
To Support India Regulatory Affairs function in various aspects including providing assistance in issue management and external engagement related activities

Key Responsibilities :
1. Coordinates and compiles dossiers & related activities for Domestic/ Import/ Export product registration/renewal for drug/ cosmetics /food /other commodities items
2. Keep tracking of all responses to regulatory agencies queries and other correspondence with regulatory authority like State FDAs, Legal Metrology, etc.
3. Reviews & approve claims, promotional materials and artworks, as applicable
4. Provides active regulatory support to Business Partners for robustness of regulatory compliance
5. Supports in activities related to Issue Management and External Engagement e.g. Interaction with Regulatory Authorities, Industry/Trade Associations, Industry colleagues, etc

6. Supports in preparing / revising internal standard operating procedures / Job aid and implementing other internal departmental practices, J&J systems and processes like Symphony, Market Authorization Review, etc.

7. Supports in departmental audit readiness (internal/external) and relevant activities.
8. Assists in preparing minutes of meeting, presentations, status reports, graph, charts, tables and slides, etc. as well as archival and maintenance of all regulatory related documentation
9. Any other assignment identified and assigned by management- time to time

Candidate Profile:
Qualification:
Technical Qualification: Master of Science
Skills: Suitable regulatory knowledge & communication skills, positive and learning attitude

Experience:  2 to 5 Years in Regulatory Affairs

Additional Information:
Experience: 2-5 years
Location: Mumbai
Job ID:  1600127188W
End Date: 25th Nov, 2016

To apply, Click here.