Job Description

Details of the requirement are given below for your reference:

1) Client Company : Pharma Industry
2) Position : Regulatory Affairs(International )
3) Experience Required : 3 to 5 + years
4) Salary Negotiable : Salary - Rs. 25000 PM to 40000 PM Depending upon candidates knowledge
5) Job Location : Ahmedabad
6) :

Job description:

1. Dossier Preparation in CTD/ACTD/Country Specific Formats

2. Re-registration and Renewal Application

3. Variation Application

4. Queries Handling

5. DMF Activity

6. Artwork Review (Carton/Foil/Label/Insert/Shipper)

7. Pack Insert Preparation as per Country Guideline

8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement.

9. 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.

Country Experience Required: Philippines, Vietnam, Cambodia, Myanmar

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)

7777981971

Job Type: Permanent

Pay: ₹30,000.00 - ₹49,697.48 per month

Work Location: In person