Recruiter at Elrich Placements Pvt Ltd
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Manager - Regulatory Affairs - Pharma - B.Pharma/M.Pharma (7-10 yrs)
We are currently having an opening for the below :
Position : Regulatory Affairs Manager (B Pharma M Pharma candidates only)
Location : MIDC, Mahape, Navi Mumbai
Qualification: B.Pharma / M. Pharma with regulatory affairs experience
Experience: 7-10 years
Salary: 09.00 L - 10.00 L
We have an opening for Regulatory Affairs Manager in a Pharma company, location is Mahape. Interested candidates may apply.
Responsibilities and Duties
1) Dossier Preparation ACTD/CTD/Country Specific for domestic or international market
2) To evaluate & respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query.
3) Dossier checking of subordinates in ACTD/CTD/Country Specific format
4) To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements
5) To Co-ordinate /to visit with respective dept. in HO /Plant /ADL/R&D for documents & samples required for dossier / registration purpose.
6) Co-ordination with API /PM vendors to resolve technical quires w.r.t. regulatory requirements.
7) Artwork Checking & development for registration and commercial purpose as per regulatory requirement.
8) To Maintain & Update all documentation & dossier record; to update registration status.
Required Experience, Skills and Qualifications
QUALITIES THE CANDIDATE MUST HAVE
- Good Communication Skils
- Analytical Skills
- Good in MS Office
Company Profile :
We believe that the essence of our Business Activity lies in the manufacturing of Quality Products and Timely deliveries,- which in turn creates value for the customer and thereby satisfaction.Since its inception this has been the guiding principle, enabling the Company to satisfy all its customers worldwide. The Company is constantly exploring possibilities to consolidate its presence and deliver value to clients.
If You Are Interested For The Above Profile Please Revert With Your Updated Resume And Mentioned The Below Details:
Reason For Job Change:
Availability For Interview: