We are hiring for Sr. Executive - Regulatory Affairs in reputed Pharma company in Ambernath location
Post: Regulatory Affairs - Sr.Executive
No. of posts: 05
Job Description
1) Dossier Preparation- Reviewing, compiling and preparation of ANDA submission (Quality module) in eCTD format
2) Supporting and providing regulatory inputs for the timely submission of response to deficiencies.
3) Approving master document: Batch manufacturing and packaging records, stability protocols, specifications etc.
4) Review of change controls and proposals
5) Effective cross functional team interaction with Product Development, Technology Transfer, Quality Assurance, Quality Control etc.
Candidate Profile
1) Review of documents required for submissions as per the ANDA checklist and guidance.
2) Knowledge of submissions covering ANDA, amendments, supplements and annual reports.
3) Experience in Solid Oral Formulations For US & EU (Regulated Market)
Additional Information:
Experience: above 3 Years
Qualification: M.sc, M.Pharm
Location: Ambernath
Functional Area: Regulatory Affairs
Industry Type: Pharma
Salary: up to 5 Lakh/anum
Last Date: 5th January, 2017
If you are interested then send your updated CV on hr1.nurture@hotmail.com
Please mention following details-
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Posted by,
Pooja
Nurture Consultancy
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