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25 USV Jobs

Manager (CMC)-RA

USV

 · 

4.0

 based on 1.4k Reviews

8-13 years

₹ 10 - 20L/yr

Mumbai

2 vacancies

Manager (CMC)-RA

USV

posted 18hr ago

Job Role Insights

Fixed timing

Key skills for the job

Europe Warehouse Regulatory Affairs

Job Description


Function: Biologics

Position: Regulatory Affairs- CMC

Job Location: Govandi (East ), Mumbai (2nd & 4th Saturday off, 1st, 3rd and 5th Saturday working)

Desired Qualification: M.Pharm/B.Pharm

Desired Work Experience: 8-12 years


Job Responsibilities:

1. Biosimilar Regulated market submissions - US / EU market submission

2. Biosimilar Product Development Strategy for CMC and Clinical

3. Review of all Dosisier related Quality documents inclusing coordination with Cross functional teams ( R&D, QC/QA and Manufacturing)

4. Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions

5. MOH Query response

6. Biosimilar Product Life Cycle Management

7. RA support for Plant related QMS activities



Employment Type: Full Time, Permanent

Read full job description

USV Interview Questions & Tips

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What people at USV are saying

3.4
 Rating based on 10 Manager reviews

Likes

Learning opportunities

Dislikes

Dysfunctional working Questionable culture Absent work life balance

  • Salary - Poor
    • +5 more
Read 10 Manager reviews

Manager salary at USV

reported by 71 employees with 10-17 years exp.
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₹10 L/yr - ₹25 L/yr
10% more than the average Manager Salary in India
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What USV employees are saying about work life

based on 1.4k employees
53%
72%
40%
97%
Strict timing
Monday to Saturday
Within city
Day Shift
View more insights

USV Benefits

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

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USV Mumbai Office Location

View all
Mumbai  (1) New Delhi  (1)
Mumbai, Maharashtra Office
Headquarter
Govandi, Mumbai, 400088, IN Mumbai, Maharashtra

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