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Regulatory Affairs-API Dr. Reddys Laboratories Ltd

By: Pharma Career | Views: 2939 | Date: 26-Feb-2011

Dr. Reddy's, recognized consistently amongst the 'Best Employers' is now the largest integrated pharmaceutical company in India and the fastest to cross USD one billion mark in revenues. With our direct presence spanning across 50 countries and with a diverse workforce of over 10000 people, we are more an India headquartered MNC.Ours is a vertically integrated company producing and delivering safe, innovative, and high quality finished dosage forms, active pharmaceutical ingredients and biological products.


Summary

Experience:
2 - 6 Years
Location:
Hyderabad / Secunderabad
Education:
UG - B.Sc - Any SpecializationPG - M.Sc - Any Specialization
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Regulatory Affairs Mgr
Functional Area:
Healthcare, Medical, R&D
Posted Date:
26 Feb

Desired Candidate Profile

B.Sc or M.Sc with relevant experience in regulatory affairs for API

Job Description

Responsibilities:

Making Amendments and updates to existing Drug Master Files / Applicants Parts.

Drafting and submission of Technical Information packages of New Active Pharmaceutical Ingredients for customers.

Drafting and Reviewing of Drug Master Files/Applicants Parts of Active Pharmaceutical Ingredients.

Making responses to Health Authorities and Customer queries.

Regulatory Submissions of said documents with regulatory agencies and customers.

Extracting information required for submissions from various departments (RND, QC, QA & Production) within the organization.

Drafting Letter of access to existing Drug Master Files and declarations/notifications for regulatory submissions and customers.

Necessary communication and assessment of outsourced intermediates/Starting materials of APIs.

Regular Updation of Regulatory Guidelines.

Timely submission of dossiers as per the monthly schedule.

Update the Regulatory Data Base.

Filing of Annual reports, DMF amendments.
Keywords: DMF regulatory

Company Profile

Dr. Reddy's, recognized consistently amongst the 'Best Employers' is now the largest integrated pharmaceutical company in India and the fastest to cross USD one billion mark in revenues. With our direct presence spanning across 50 countries and with a diverse workforce of over 10000 people, we are more an India headquartered MNC.
Ours is a vertically integrated company producing and delivering safe, innovative, and high quality finished dosage forms, active pharmaceutical ingredients and biological products. Our strong portfolio of businesses, geographies and products provide us the strategic benefits of vertical integration that allow us to excel in an increasingly competitive global market. We are dedicated to bringing affordable healthcare to people across the world, regardless of geographic and socio-economic barriers.
At Dr. Reddy’s, career is not just about vertical growth. It is enhancing true competence. It is about taking intelligent risks with people. It is about trust. It is about breakthrough performance. It is about you. We respect talent. We respect you.
Contact Details
Company Name:
Dr. Reddys Laboratories Ltd..
Executive Name:
Noel.T.Rajan
Address:
Dr Reddys Laboratories Ltd
7-1-27 Ameerpet
HYDERABAD,Andhra Pradesh,India 500016
Email Address:
Telephone:
91-40-44346576

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