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15 Harman Finochem Jobs

Regulatory Affairs Specialist

4-9 years

₹ 2.5 - 6.5L/yr

Aurangabad

1 vacancy

Regulatory Affairs Specialist

Harman Finochem

posted 28d ago

Job Description

Role & responsibilities

- Review, compile and submit the Application dossiers (ANDA, MAA) to regulatory agencies like US-FDA, EMA, Health Canada, Australia and ROW countries.

- Review and approve regulatory CMC documents being generated at R&D and commercial manufacturing facility such as development reports, BMR, BPR, Specifications, method validation reports, process validation reports, stability protocols, stability data etc. and ensure regulatory compliance.

- Maintenance of the complete history of each Drug products (Filing history with agencies/customers, amendments).To coordinate in regulatory audits and provide regulatory support.

- Coordination with internal and external stakeholders for regulatory filing related documentation.

- Communicate the agency's comments/deficiencies to respective in house departments, prepare the response and submit it back to the agency.

- Hands on experience of post approval variations and Annual reports.


Preferred candidate profile

Master of Pharmacy


Perks and benefits

As per Company Standards



Employment Type: Full Time, Permanent

Read full job description

Prepare for Regulatory Affairs Specialist roles with real interview advice

Top Harman Finochem Regulatory Affairs Specialist Interview Questions

Q1. What is your experience with operating packing machines? 11 years 1 month
Q2. Micron size or SF pad filter and filter of zeta filter
Q3. WHAT IS QAMS AND HOW IT IS USEFUL INSTEAD OF MANUAL SUBMITTING CC IN HARD COPY
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What people at Harman Finochem are saying

Regulatory Affairs Specialist salary at Harman Finochem

reported by 1 employee with 4 years exp.
₹4.9 L/yr - ₹6.2 L/yr
34% less than the average Regulatory Affairs Specialist Salary in India
View more details

What Harman Finochem employees are saying about work life

based on 397 employees
64%
61%
53%
97%
Strict timing
Monday to Saturday
No travel
Day Shift
View more insights

Harman Finochem Benefits

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

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