IRA US - Artwork/Labelling (Fresher)

\n

Sr.

\n\n

Job Responsibilities

\n\n

1.

\n\n

Post approval labeling activities

\n

·         RLD revision

\n

·         Safety notification

\n

·         Annual reportable changes

\n

·         USP claim

\n

·         Change control

\n

·         NPIF review

\n

·         Proof approval

\n

·         LIF review

\n

·         Artwork Management

\n

·         Drug listing

\n

·         Launch related activities

\n

·         APQR preparation for labeling

\n\n

2.

\n\n

Deficiency Response labeling

\n

·         Easily correctable deficiency/ Discipline review letter

\n

·         Information Request

\n

·         Complete Response letter

\n

·         Screening deficiency

\n

·         Labeling Amendment

\n\n

3.

\n\n

ANDA labeling

\n

·         Identification of RLD for reference labeling.

\n

·         Collection of RLD and in house samples for labeling preparation

\n

·         Draft preparation for labeling components

\n

·         Preparation of module 1.14 and 1.16

\n\n

4.

\n\n

NDC code allotment and maintenance for US market

\n\n

5.

\n\n

REMS related submission

\n\n

6.

\n\n

Interact with cross functional teams

\n\n

7.

\n\n

Revision of labeling after patent or exclusivity expiration

\n\n

8.

\n\n

Labeling activities for third parties

\n\n

9.

\n\n

Data maintenance and archiving

\n\n

10.

\n\n

Implement of new regulatory requirements by analyzing their impact on the
labeling.

\n\n

11.

\n\n

Monitoring electronic submission of labeling.

\n\n

12.

\n\n

To prepare and implement SOP.

\n\n

13.

\n\n

CHL to ZLL update for all the Products.

\n\n

14.

\n\n

To Provide Business Oriented Regulatory intelligence.

\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n

Any Graduate