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5 ProductLife Group Jobs
Regulatory Affairs Officer
2-6 years
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Regulatory Affairs Officer
ProductLife Group
posted 6hr ago
Job Role Insights
Fixed timing
Key skills for the job
Job Description
Specific activities and responsibilities:
- Regulatory Assessment for Quality and Safety changes (inc labelling updates and non CMC administrative changes)
- Creation/update Country Label Deviation
- Update and approval local artworks
- Provision of local reg intel
- Update local site licenses (GMP site renewals)
- Local Regulatory SOP review and update
- Health Authority Fee maintenance
- Coordinate of Response to Questions
- Preparation/update Product Information
- Preparation /update local abbreviated PI (if applicable)
- Preparation of Renewal Procedure eg local document identification and preparation
- Preparation for Variations inc. RtQs, requesting/securing centrally provided documentation
- Preparation for Annual Safety Updates/HA instructed safety updates
- Regulatory support in relation to local requirements relating to cessation of marketing / sunset clause / withdrawal of Mas
Providing support during external and unannounced audits.
- Degree in life sciences related field
- 4+ years RA experience
- RA knowledge and background, MS-Excel basic and Presentation skills, coordination / organizational / multi task skills
- Organized, methodical, adaptable, sense of priorities, rational, ready to learn and grow.
Employment Type: Full Time, Permanent
Read full job description What people at ProductLife Group are saying
Rating based on 1 Regulatory Affairs Officer
review
Anonymous · Regulatory Affairs
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Salary benefits
Read 1 reviewRegulatory Affairs Officer salary at ProductLife Group
reported by
2
employees
with 5-6
years exp.
₹5.4
L/yr - ₹6.9
L/yr
86%
more
than the average Regulatory Affairs Officer Salary in India
View more details
What ProductLife Group employees are saying about work life
based on 8 employees
Strict (10.30am - 7pm)
Monday to Friday
No travel
Day Shift
ProductLife Group Benefits
View more benefits
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