International Regulatory Affairs
5 days ago
Details of the requirement are given below for your reference:
1) Client Company : Pharmaceutical Industry
2) Position : International Regulatory Affairs
3) Experience Required : 3 to 5 + years
4) Salary Negotiable : Salary - Rs PM to 40000 PM Depending upon candidates knowledge
5) Job Location : Ahmedabad
6) Job Description :
Job description:
Dossier Preparation in CTD/ACTD/Country Specific Formats
Re-registration and Renewal Application
Variation Application
Queries Handling
DMF Activity
Artwork Review (Carton/Foil/Label/Insert/Shipper)
Pack Insert Preparation as per Country Guideline
Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement.
Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study.
Dosage Form Experience Required:
Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.
Interested candidates can apply immediately.
With Regards,
Gopi (HR)
Job Type: Permanent
Pay: ₹25, ₹40,000.00 per month
Work Location: In person
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