Roles and Responsibilities :
1. Responsible for Dossier compilation:
- To prepare New, Renewal dossier and variations (Site/ Formula) of South Asia, LATAM countries and having specific knowledge for China, South Africa and Brazil filing and Regulatory knowledge of Guidelines viz, ICH , FDA PICs etc.
- To review accuracy of executed data before submission - Plant generated validation reports and raw data as required to ensure compliance before Dossier submission.
- To review of documents for adequacy and accuracy.
- To ensure regulatory compliance and liaison with countries / regulatory authorities during the product registration process.
- To arrange the samples as per country requirements.
2. Responsible for Tender compilation:
- To gather, evaluate, organize, manage and collate information/ documents requirements for Tender fillings for WHO/UNICEF/MSF
3. Ensure timely delivery of regulatory query:
- To review and ensure accuracy of deficiency response for Quality , Clinical part of dossier.
- To evaluate the query received for registered or under registration products and Tender products and also to support for completion of the same in timely manner.
4. Other activities:
- To maintain Data Bank for Commercial activity.
- To work with quality standards and adherence to system.
5. Compliance (Audits / Audit Readiness)
- Support in Site Audit Readiness and Compliance relevant to RA functions / procedures based on external / internal audits.
- To Audit Alkem sites to verify the executed documents (Process validation Protocol and reports and BMRs/BPRs) and its accuracy and readiness as per GDP and GMP norms.
Salary: Not Disclosed by Recruiter
Industry:Pharmaceutical & Life Sciences
Functional Area:Healthcare & Life Sciences
Role Category:Other Hospital Staff
Employment Type:Full Time, Permanent
PG:M.Pharma in Any Specialization
Alkem Laboratories Ltd
Contact Company:Alkem Laboratories
Address:Alkem Laboratories Ltd (R&D), C-6/1 C-6/2 C-17/7, Dist, Industrial Estate, Taloja Police Station,Taloja, Navi Mumbai, Maharashtra 410208