Name:

Employee id:

Job Title:

Sr.Executive - RA

Job Grade:

G11B

Function:

Plant Regulatory Affairs

Sub-function:

Plant Regulatory Affairs

Managers Job Title:

DGM

Skip Level Managers Title:

NA

Function Head Title:

Sr.Vice President

Location:

Dadra

No. of Direct Reports (if any)

None

Date of Joining:

Job Summary

Manage work related to Regulatory Affairs functions at Site

.

Areas Of Responsibility

1

Monitoring for Documents compilation activities for New product filing , Re-Registration/renewals from plant dossier filing , sample requirements etc.

2

Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant.

3

Coordination with CRA, ADD, FDD, MSTG ,PMO ,Plant team and with other CFT Members for regulatory requirements related to Registration, Re-Registration, queries, and variation filing.

4

Product Life Cycle Management: Active participation in Change control committee meeting. Discussion with different Stakeholders and decision for final variation category (After taking concurrence from CRA, Country RA and Customers if require).

5

Activities related to Variation management - Tracking of Variation filing, approvals and intimation to plant for implementation of changes.

6

Support plant for business continuity of products by filing variations wherever applicable.

7

Monitoring for circulation of Regulatory Approvals and commitment details to Plant Team for US and OAM and Approval package for emerging market.

8

Participation in all launch discussions with plant CFT , business team , CRA to identify gap & mitigation plan.

9

Circulation of Regulatory strategies and Guidelines, wherever applicable

10

Support plant during Regulatory Inspections.

Travel Estimate

Up to %

Job Scope

Internal Interactions (within the organization)

Production/ Quality/MSTG/NPQC/CRA/FDD/ADD/PDD

External Interactions (outside the organization)

Customers / Country RA

Geographical Scope

Dadra

Financial Accountability (cost/revenue with exclusive authority)

N/A

Job Requirements

Educational Qualification

M.Sc. /B.Pharm/M.Pharm

Specific Certification

N/A

Skills

Believe in Team work,

Leadership Skills

, Communication Skills

Experience

7-8 Years

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.