A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Global Regulatory Affairs GL Regulatory Specialist I/II
Job Description:
Job Purpose (State in one sentence the overall objective of the role) Independently handle and supervise other GLMs, Global Labeling (GL) category activities, liaise with Research and Development (R&D) Global Line Functions (GLF), regional or country Regulatory Affairs (RA) organizations in the development and execution of global Product Information (PI) documents for the projects.
Major Accountabilities (Describe the main results of the role to be achieved )
• Global Product Information: create and maintain regulatory compliant, competitive and up to date global labeling documents and support other GLMs on labeling activities.
• Execute the development of Core Product Information (cPI) documents: Core Safety Information (CSI), Core Data Sheet (CDS), Core Patient Information Leaflet (cPIL), Basic Succinct Statement (BSS), regional Summary of Product Characteristics (rSmPC); and their implementation to the local/national PIs.
• Manage all other relevant PI documents for all product categories. Review, comment and provide professional support for all PI documents with authoring and with global labeling expertise.
• Present proposed changes in global product information documents to the GLC for review and approval.
• Liaize, lead, discuss, and negotiate (as necessary) with R&D categories, R&D Category Regulatory Leaders (GRL), GRA categories and GRA regions, GLFs and country RA (CO RA) to ensure timely implementation of global labeling changes in core and local product information, and ensure international consistency and compliance with the cPI documents.
• Periodic Safety Update Report (PSUR): Provide high quality and timely global regulatory input to PSURs for assigned product categories, and follow up on potential cPI commitments in PSURs.
• Independently address Health Authority/affiliate Questions related to PI Documents.
• Contribute to special assigned activities and projects within the team or represent GRA in cross-functional assignments & projects, as necessary.
• Supervise other junior labeling team members in performing the task.
• Support Regulatory Intelligence Team to collect, interpret and distribute relevant information. Maintains a general knowledge of regulatory requirements for all countries supported.
Candidate Profile:
Education Post--graduation in life sciences, Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent), or PhD in Life Sciences.
A minimum of 3 years of relevant industrial experience.
Additional Information:
Location: Hyderabad
Education: MBBS/MD, Post--graduation in life sciences
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 105347BR
End Date: 15th Oct, 2012
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