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2 Hetero Drugs Executive Regulatory Affairs Jobs
Regulatory Affairs Executive (API)
Hetero Drugs
posted 7d ago
Job Description
- Preparation and Compilation of DMFs in-line with regulations of Regulatory and Semi-Regulatory countries.
- Supporting to the concerned Marketing department/teams in terms of providing appropriate documents.
- Coordinating effectively with all cross functional teams (QC, QA, R&D, and Production) to procure the documents and to develop the documents required for compilation of API DMFs.
- Attending calls/Meetings with marketing teams, customers and plants regarding regulatory related issues as and when required.
- Development of DMFs for registration of products in countries like US, Europe, Brazil, China, Russia markets.
- Collecting, collating and evaluating scientific data received from plant/R&D.
- Responsible for timely planning, coordination and submission of API DMFs/deficiencies in EMT markets.
- Review of documents and compilation, identifying gaps, ensure suitability, acceptance etc.
- Guidance to cross-functional teams and team members on EMT regulatory strategy and regional regulatory requirements.
- Timely quality response to external customers on technical queries and requests.
- Life Cycle management of the products.
- Maintain compliance with the regulatory requirements.
Employment Type: Full Time, Permanent
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People are getting interviews at Hetero Drugs through
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(based on 132 Hetero Drugs interviews)
Walkin
Job Portal
Referral
Company Website
Campus Placement
Recruitment Consultant
25%
20%
17%
13%
9%
2%
14% candidates got the interview through other sources.
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What Executive Regulatory Affairs at Hetero Drugs are saying
Rating based on 3 Executive Regulatory Affairs
reviews
Anonymous · Banking Operations
in Hyderabad/Secunderabad
Likes
good
Dislikes
low salary and benfits
Read 3 reviewsExecutive Regulatory Affairs salary at Hetero Drugs
reported by
14
employees
with 5-7
years exp.
₹4.5
L/yr - ₹6.9
L/yr
29%
more
than the average Executive Regulatory Affairs Salary in India
View more details
What Hetero Drugs employees are saying about work life
based on 3k employees
Flexible timing
Monday to Saturday
Within city
Day Shift
Hetero Drugs Benefits
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