Job Description

Name:
Employee id:
Job Title:
Sr.Executive - RA
Job Grade:
G11B
Function:
Plant Regulatory Affairs
Sub-function:
Plant Regulatory Affairs
Manager\'s Job Title:
DGM
Skip Level Manager\'s Title:
NA
Function Head Title:
Sr.Vice President
Location:
Halol
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.
11
Monitoring for Product permissions, test licences and lay out archival activities for Local FDA .
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
Halol
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
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).