MANAGER- REGULATORY FUNCTION

Summary

Experience:

2 - 5 Years

Location:

Mumbai

Compensation:

No constrain for right candidate

Education:

UG - B.Pharma - Pharmacy,MBBS - MedicinePG - M.Pharma - Pharmacy,M.S/M.D - Any Specialization

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Regulatory Affairs Mgr

Functional Area:

Healthcare, Medical, R&D

Posted Date:

13 Apr

Desired Candidate Profile

M Pharm / MBBS / MD with similar experience .

Job Description

Sahll be responsible for

• Compilation of registration dossiers for product and company registration.

• Responding to technical queries related to product registration.

• Discussing with various doctors and investigators for preparation of Clinical trial protocol & Case Record Form.

• Guidance to team members to prepare Protocol and Case Record Form for conducting Clinical trial.

• Building of in-house document control system to support registration activities.

• Preparation of Site Master files of production units.

• Co-ordination with various departments for technical documents, reports and samples.

• Application to DCG(I) for manufacturing site registration, manufacturing and marketing of new drug formulation, import license application,

Keywords: Registration dossiers for product and company registration., preparation of Clinical trial protocol, Preparation of Site Master files of production units. Application to DCGI for manufacturing site registration.

Company Profile

One of the TOP ranking pharma company .The Company develops and markets a wide range of quality, affordable generic and branded formulations and APIs in multiple markets across the world.

In Domestic market, the products are brand leader & and has achieved a formidable position in many segments. The company is growing ahead of the industry.

In International developed market, it has developed a robust branded and generic business and has been recognized as one of the fastest growing Companies.

The manufacturing facilities, spread across India, are approved by international regulatory agencies like US FDA, UK MHRA, TGA Australia, WHO, and MCC South Africa.
The company’s main focus in R&D is on drug discovery and advanced drug delivery systems research. The Company’s overall research prowess enables it to master cutting edge science and technology.

To sum up. Best in class organization, offers a stimulating work environment where competent & career minded professionals are nurtured & rewarded.