Location: Airoli, MH, IN
Company: Lupin
A) Job description: –
1. Preparation of Drug Master file for all markets.
2. Preparation of Technical Package.
3. Review of documents – Specifications, Batch Manufacturing records, etc.
4. Compilation of deficiency responses and review of related documents.
5. Issuance of different type of declarations, loas as required for various markets.
B) Relevant work experience – 1 to 2 Years.
C) Education Qualification – Post Graduate.
Location: Airoli, MH, IN
Company: Lupin
A) Job description:-
1. To have good understanding of P2P Shared Service operations and experience of P2P Help Desk / Service Desk.
2. To ensure timely, respond all the Helpdesk / Service Desk queries as per internal guidelines.
3. Strong written, oral and analytical skills.
4. Supporting the Manager in Helpdesk Reporting and escalation management. etc.
5. Experience in working on SAP, Excel & workflow system.
6. Experience of customer relations management for Vendor Help Desk / Service Desk role
B) Relevant work experience – 7 to 9 Years.
C) Education Qualification – M. Com / B. Com
Executive – Regulatory Affairs US
Location: Airoli, IN
Company: Lupin
A) Job description: –
1. Handling of post approval submissions.
2. Evaluate and respond to FDA deficiencies in timely manner.
3. Evaluate change proposals to define Regulatory strategy.
4. Handling Annual Reports for approved products.
5. Handling labeling changes to support changes in RLD labeling.
6. To provide support to PSUR activities.
7. Review and comments on product development, scale-up and commercial stage documents.
8. To handle document review of site documents supporting change proposals.
B) Relevant work experience – 1 to 6 Years.
C) Education Qualification – B. Pharma.
Location: Santacruz, MH, IN
Company: Lupin
A) Job description :-
1. Assisting bank-work connected with bank-limits / documentation / compliances / follow-up, etc.
2. Lenders / Banking Compliances – Monthly / Quarterly / Yearly.
3. Leasing documentation / MIS.
4. Various Treasury MIS.
5. Verification of all bank invoices from banks connected with treasury transaction.
6. Co-ordination with Shared Service Team connected with SAP work.
7. Knowledge of SAP accounting.
B) Education qualification – M. Com / MBA (Finance)
C) Work experience – 4 Years +
Location: Airoli, MH, IN
Company: Lupin
A) Job description: –
1. Review of new ANDA submission for Oral,Opthal, Injectable and Inhalation products.
2. Evaluate and respond to ANDA deficiencies in timely manner.
3. Responsible for Finalizing documents needed for submission of New NDA, ANDA and Amendments.
4. Handling of Post approval supplements.
5. Handling Annual Reports for approved products
6. Publishing activities for all type of submissions.
7. Review and comments on product development, scale-up and commercial stage documents.
8. To provide support to PSUR activities.
B) Relevant work experience – 4 to10 Years.
C) Education Qualification – M. Pharma / B. Pharma
Location: Airoli, MH, IN
Company: Lupin
A) Job description: –
1. Handling new ANDA submission for Oral, injectable and Inhalation products.
2. Evaluate and respond to ANDA deficiencies in timely manner.
3. Handling of Post approval submissions.
4. Handling Annual Reports for approved products.
5. Handling labeling changes to support changes in RLD labeling.
6. To provide support to PSUR activities.
7. Review and comments on product development, scale-up and commercial stage documents.
8. To handle documents, review for out manufactured products.
B) Relevant work experience – 1 to 6 Years.
C) Education Qualification – M. Pharma / B. Pharma / M.Sc.
