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38 Hetero Jobs
Formulation Regulatory Affairs Executive/ Assistant Manager
Hetero
·
3-8 years
Hyderabad / Secunderabad
15 vacancies
Formulation Regulatory Affairs Executive/ Assistant Manager
Hetero
posted 6 days ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Role & responsibilities
- Keen Knowledge on Regulatory guidelines for finished product registration.
- Dossier compilation as per guidelines.
- Compilation and review the product dossiers for submission in CTD, ACTD.
- Gap analysis of the dossier and addressing the gaps before submission to MOH.
- Handling the customer and MOH queries.
- Life cycle management of the product.
- Development report, scale up report, specification, COA, stability protocol and Process validation protocol.
- Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability).
- Post approval experience to file the applicable variations timely.
- Knowledge on EAEU, ICH and EMEA guidelines.
- Re-registration (Renewal) procedures.
- Administrative documents requirements (COPP, Mfg. License and Import License) .
- Registration information management system updates on regular basis.
Employment Type: Full Time, Permanent
Read full job description
What people at Hetero are saying
Rating based on 6 Executive Regulatory Affairs
reviews
Anonymous · Other
in Hyderabad / Secunderabad
Likes
I enjoy a positive and fruitful work environment under the guidance of my Assistant Manager, Mr. Hareesh Kumar Reddy Revuri
- Skill development - Good
Dislikes
I have bad experience with Leave policy
- Promotions - Poor
+2 more
Executive Regulatory Affairs salary at Hetero
reported by
30
employees
with 3-7
years exp.
₹2.8
L/yr - ₹7
L/yr
11%
more
than the average Executive Regulatory Affairs Salary in India
View more details
What Hetero employees are saying about work life
based on 3.7k employees
Flexible timing
Monday to Saturday
Within city
Day Shift
Hetero Benefits
Submitted by Company
Employee Friendly Policies Personal Development and Training Reward and Recognition Recreation and Sports Events Unique Benefits Health/Life/Medical Insurance
Submitted by Employees
View more benefits 
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Hetero Hyderabad / Secunderabad Office Location
Hyderabad / Secunderabad, Telangana Office
Headquarter
Floor 9-11, Tower 30, RMZ Nexity, Sy. No. 83/1, Knowledge City, Raidurg, Hyderabad - 500081, Telangana, India
Hyderabad / Secunderabad, Telangana
500081
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