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274 Abbott Jobs

Manager Regulatory Affairs

8-10 years

₹ 12.35 - 20.4L/yr (AmbitionBox estimate)

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This is an estimate of the average salary range for this position. It has not been reviewed by the company, and the actual salary may differ.

Mumbai

1 vacancy

Manager Regulatory Affairs

Abbott

posted 17d ago

Job Description

Key Accountabilities :
Propose efficient regulatory pathway for New Product Introduction
Develop & implement regulatory strategies for new/generic product registrations in
compliance with relevant regulations and the business needs
Provide regulatory input to CMC data, BE & CT protocol, study waiver justification etc.
related to new products filing
Collaborate with other functions such as R&D, Quality, Supply chain, Project
Management, Medical, Clinical etc to deliver high quality dossiers, in accordance with
business priorities
Responsible for end-to-end filing of New products(Drugs / Biologics / Biosimilars etc) to
CDSCO (Central Drugs Standard Control Organization), State FDA etc.
Well versed with filing application of ND/SND/FDC/Import Registration/Import licence
etc on SUGAM portal
Address queries from CDSCO/SFDA on submitted applications, provide regulatory
support for IPC/CDTL/CDL testing
Manage submission of application dossiers with relevant regulatory authorities, monitor
the review process and take appropriate actions to obtain regulatory approvals as planned.
Responsible for Subject expert committee (SEC) meetings including preparation of slide
deck in co-ordination with cross functional teams and SEC deliberation
Track all SEC meetings to identify and recommend new product ideas/opportunities
aligned with current business needs
Provide Regulatory Support for timely new product launches
Minimum Education:
M. Pharm/B. Pharm
Minimum Experience Required:
8-10 years

Employment Type: Full Time, Permanent

Read full job description

Prepare for Regulatory Affairs Manager roles with real interview advice

Top Abbott Regulatory Affairs Manager Interview Questions

Q1. What is the role of therapy business manager or Medical Representative
Q2. Safety culture developments and its impact
Q3. How can you convince doctor and chemist to sell our product
View all 68 questions

What people at Abbott are saying

Regulatory Affairs Manager salary at Abbott

reported by 19 employees with 8-15 years exp.
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₹12.3 L/yr - ₹23 L/yr
8% more than the average Regulatory Affairs Manager Salary in India
View more details

What Abbott employees are saying about work life

based on 3.1k employees
71%
48%
45%
96%
Flexible timing
Monday to Saturday
Within city
Day Shift
View more insights

Abbott Benefits

Submitted by Company
Healthcare
Incentive program
Vacation & Holidays
Life insurance
Submitted by Employees
Health Insurance
Job Training
Soft Skill Training
Free Transport
Education Assistance
Work From Home +6 more
View more benefits

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Abbott Mumbai Office Locations

View all
Mumbai Office
Headquarter
271, Business Park, Model Industrial Colony, Off Aarey Road, Goregaon (E) Mumbai
Maharashtra 400063
Mumbai Office
Abbott Laboratories (India) Limited, Padmaja Apartment-a, Yari Road, Versova, Versova Mumbai
Maharashtra 400061

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