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Regulatory Affairs Executive/ Asst. Manager
Hetero
·
3-8 years
Hyderabad / Secunderabad
10 vacancies
Regulatory Affairs Executive/ Asst. Manager
Hetero
posted 3d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Job Description:
- Keen Knowledge on Regulatory guidelines for finished product registration.
- Dossier compilation as per EAEU 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
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What people at Hetero are saying
Rating based on 5 Executive Regulatory Affairs
reviews
Anonymous · Other
in Hyderabad / Secunderabad
I enjoy a positive and fruitful work environment under the guidance of my Assistant Manager, Mr. Hareesh Kumar Reddy Revuri
- Skill development - Good
I have bad experience with Leave policy
- Promotions - Poor
Executive Regulatory Affairs salary at Hetero
What Hetero employees are saying about work life
Hetero Benefits
Employee Friendly Policies Personal Development and Training Reward and Recognition Recreation and Sports Events Unique Benefits Health/Life/Medical Insurance 
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