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33 Hetero Jobs

Formulation Regulatory Affairs Executive/ Assistant Manager

3-8 years

Hyderabad / Secunderabad

15 vacancies

Formulation Regulatory Affairs Executive/ Assistant Manager

Hetero

posted 3d ago

Job Role Insights

Flexible timing

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

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What people at Hetero are saying

2.8
 Rating based on 5 Executive Regulatory Affairs reviews

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
Read 5 Executive Regulatory Affairs reviews

Executive Regulatory Affairs salary at Hetero

reported by 29 employees with 3-7 years exp.
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₹3.2 L/yr - ₹7 L/yr
18% more than the average Executive Regulatory Affairs Salary in India
View more details

What Hetero employees are saying about work life

based on 3.3k employees
51%
62%
45%
98%
Flexible timing
Monday to Saturday
Within city
Day Shift
View more insights

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
Job Training
Health Insurance
Soft Skill Training
Free Transport
Cafeteria
Free Food +6 more
View more benefits

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Hetero Hyderabad / Secunderabad Office Location

View all
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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