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CTA Officer
ProductLife Group
posted 6hr ago
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Fixed timing
Key skills for the job
Job Description
Specific activities and responsibilities:
- Contribute to regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.
- To contribute to the production of client administrative documents to be included in regulatory submissions
- Compile regulatory dossiers in accordance with national requirements.
- Systems Management and Administration
- Document and track regulatory submissions and regulatory authority approval.
- Provide regulatory support to clients and associate companies.
- Liaise with sponsor head-office and affiliate departments on regulatory issues.
- Provide review of packaging texts.
- Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
- Provide on-going regulatory support to the Regulatory Affairs Specialist and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
- Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services supplied by the platform/hub.
- University background and/or experience in Regulatory affairs - Module 1 and EU Regulations
- Bachelor s degree in a science related field
- 4 to 5 years of experience in Regulatory Affairs
- Excellent organizational and interpersonal skills
- Ability to work well within a team
- Process orientated with good attention to detail
- Good computer skills and the ability to learn appropriate software
- Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
- Fluency in English (Spoken and Written)
Employment Type: Full Time, Permanent
Read full job description What people at ProductLife Group are saying
Officer salary at ProductLife Group
reported by
3
employees
₹4.5
L/yr - ₹8.5
L/yr
51%
more
than the average 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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