Ind Swift Laboratories Ltd. Established in 1995 Ind-Swift has fast evolved towards a business model that is focused on deep-rooted domestic presence and leveraged on high-value mature regulated markets along with considerable growth in emerging markets.
Post : Officer - Regulatory Affairs
No of posts : 04
Job Description
1. Literature search, review and preparation of Clinical and non clinical modules for ROW submissions.
2. Filling of BE Application form for ROW submissions
3. Preparation PI/SPC/PIL
4. Timely updation of PI/SPC/PIL and handling of query from Regulatory and their response
5. Maintain of record for PI/SPC/PIL for each country and their updation as per requirement or as per changes in safety information in innovator PI/SPC/PIL.
6. Application of T-license for the import
7. Compilation of Documents for application of bio T-license and BE NOC.
8. Maintain of all records related to internal and external communications with CROs for BE study including payment.
9. Maintain of record of reference samples as well as test samples for BE studies
10. Maintain of record for communication and safety data exchange information for Pharmacovigilance
11. Maintain of record of report adverse events and their response.
12. Preparation of Risk assessment of Product manufactured at GBU site (Toxicological data).
Candidate Profile :
The candidate should be an M Pharma
having experience in Regulatory Affairs setup will be an added advantage
Additional Information:
Experience: 0-1 yrs
Qualification: M.Pharm
Salary: INR 1,00,000 - 2,50,000 P.A
Location: Chandigarh
Industry Type: Pharma
Last date: 28th, January, 2017
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