Responsible for Product lifecycle management and Post approval activities:
- Evaluation of change controls/GOS/Deviations for impact assessment.
- Responsible for sharing change control with EU customers for customer approval.
- Timely evaluation of gap assessment for approved documents and existing documents. Implementation of cost effective approach for commercial products to improve lifecycle management.
- Planning of variation submission.
- Co-ordination with EU customers to accelerate variation planning and to collect relevant documents required for variation submission.
- Review & submission of variation application in line with regulatory requirements/Agency's expectation.
- Responsible for sharing eCTD sequences (variation) to customers.
- Co-ordination with EU/AU agency for progress of variation application (on need basis).
- Implementation of approved changes.
- Facilitate EU Qualified Person (QP) batch release by resolving queries and providing necessary information.
- Facilitate commercial activities.
- Maintenance of product lifecycle status.
Responsible for Submission Process Improvement and Compliance with Regulatory Updates:
- Innovation in existing process by implementing different approaches.
- Up-gradation of softwares (CESP, PharmaReady and eValidators).
- Up-gradation of European/British Pharmacopoeia Sharing current guidelines/legislations to
Role:Manager - R & D
Salary: Not Disclosed by Recruiter
Industry:Pharmaceutical & Life Sciences
Functional Area:Research & Development
Role Category:Pharmaceutical & Biotechnology
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
Reference Id:DRA - EU