Manager - 2 - Regulatory Affairs

Job Summary

Manage work related to Regulatory Affairs functions at Site

Areas Of Responsibility

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

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

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.

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).

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

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

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

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

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.

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

10-12 Years