Regulatory Affairs Associate (injectables & Regulated Markets Only) ~ pharmastuff.blogspot.com

Regulatory Affairs Associate (injectables & Regulated Markets Only)

Regulatory Affairs Associate - Baxter pharmaceuticals India private limited provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis , infusion systems, sterile IV solutions and devices ,parenteral nutrition, surgery products and anesthetics and pharmacy automation, software and services.

The company is having opening of Regulatory Affairs Associate .Interested candidate can check the details below

Job Description

1.Preparing impact assessment of change control/change cases and discussing with superior with respect to all Regulated markets

2.Finalization of variation category in consulting with superior for different regulated markets where product is filed

3.Collection and compilation of data with regards to variation package

4.Preparing variation dossier

5.Preparing response to queries

6.Ensuring timely submission as per variation schedule.

7.Coordinating with internal stakeholders for package finalization .

8.Data collection from various functions at plant

9.Preparation of annual submission package

10.Submission of annual package

Salary: INR 4,00,000 - 6,00,000 P.A.

Location – Ahmedabad ,India

Experience Required – 3 to 6 years

Desired Candidate Profile

-Knowledge in regulatory guidelines and QMS

-Technical writing skills

Education-

UG:B.Pharma - Pharmacy

PG:M.Pharma - Pharmacy

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