International Regulatory Affairs

5 days ago


Ahmedabad, Gujarat, India WFA Construction Full time

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:

  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.

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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