Team Lead - Regulatory Affairs (Pharma MNC)

IndiHire HR Consultants Pvt. Ltd.
  • Mumbai
  • Confidential
  • 2-7 years
  • 12 Aug 2015

  • Compliance/ Regulatory

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Core Job Responsibilities:

Manage Registration Management staff
Tracking and reporting of Registration Management team activities
Analyze reports and metrics from tracking tools; identify trends and ramifications.
Provide Registration tracking and commitments input and reporting
Monitor and submit applicable reports to regulatory management regulatory stakeholders
Input to global leadership on local issues and impacts on global Regulatory Operations organization
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Implement internal process and standards relating to registration management
Identifies and implement opportunities for improved business processes and efficiencies
Training of staff
Schedules, conducts and documents team meetings as deemed necessary.
Work with IT and/or vendor on business problem resolution and enhancements.
Identifies needed project management tools. Directs the development, deployment and application of those tools.
Interfaces with other departments to understand organizational processes and priorities.

Desired Candidate Profile

Bachelor or Master Degree in Information Management, Bio Science, Business Administration or equivalent
3-5 years experience in registration management or related areas
Demonstrated leadership capabilities in Project Management and/or People Management
Understanding of cross-functional interdependencies within a Pharmaceutical organization
Expertise with registration management systems
Knowledge of regulations and instructions

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