Manager – Regulatory Affairs

From 10 to 14 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

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
    team members.


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

Key Skills
Skills highlighted with ‘‘ are preferred keyskills

Education

PG:M.Pharma in Any Specialization

Company Profile

Alkem Laboratories

Alkem Laboratories Ltd

Company Info
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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