Intas Pharmaceuticals
Location
Ahmedabad | India
Job description
1. To lead the artwork team involved in product mockup and artworks and guide them time to time and resolve the queries. The role is a managerial role for labelling and artwork activities for EMENA region. The role involves the activities of labelling requirements of Regulatory Module 1.
2. Cross functional communication with EMENA team and CMO to ensure timely update and establish the relationship.
3. Coordination with New Product Launch (NPL) and other functions as applicable to update the progress of MA/ Artworks to enable organization to meet launch timeline.
4. The development of product information along with mockup for national phase submission after closure of procedure (DCP/ MRP/ CP). The activity associated with Regulatory Module 1 to support core team to file the application/variation.
5. The generation of responses to regulatory agency questions related to artwork components.
6. The development of artwork through effective coordination with various team such as packaging development/ commercial/ logistics/ marketing and manufacturing facility.
7. Execute strategy/ planning of mockup / variation submission for upcoming submission deadline.
8. Plan the weekly and monthly work for the team.
9. Monitor/ guide/ train the team for safety variation activity and ensure PV compliance maintain at all levels of safety variation activity.
10. The maintenance of product information (SmPC/ PIL) database and version control in line new Marketing authorization detail. Additionally, product information database to maintain for safety variation.
11. The monitoring of Marketing authorization/ Variation tracker to maintain accuracy of authorization detail and real time data available.
12. Awareness and application of relevant pharmaceutical regulation of EU/UK region and new guidelines/policies relevant to product information/ labelling and Marketing authorization procedure or requirements.
13. To coordinate with CMO and develop strategy for artwork finalization & implementation.
14. To ensure Change control mechanism is followed, changes are tracked, and artworks are timely issued. To do the effectiveness checks on change control mechanism.
15. Periodically do gap analysis from National labelling update from EU/UK region and train the team.
16. KPI monitoring and ensuring the team is organized and guided to achieve the KPIs.
Job tags
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