Novartis is a global healthcare leader and has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field. We appreciate and welcome your interest in joining our team of associates from more than 150 nationalities who currently share our mission to care and to cure.
Job ID : 224130BR
Position Title : Expert – GxP & Regulatory Intelligence
Division : NBS
Business Unit : PLS NBS
Country : India
Work Location : Hyderabad
Job Description :
Responsibility for
ensuring high quality clinical trial data review as directed by the Clinical Trial Team (CTT):- Gather and analyze information on changes in laws, directives, regulations, guidance documents and consensus documents that are applicable to GxP regulated activities to provide assessment of impact of these changes.
- Process targeted internal and external GxP and regulatory information from multiple sources and deliver the following as per agreed SLAs (timeliness, accuracy, quality, etc): o Dashboard and metric reports o Knowledge Management reports o Other ad-hoc trends and analysis
- Issue internal communication of GxP and regulatory changes to the right stakeholders through newsletters, presentations or other means as and when required.
- Maintain complete awareness of GxP relevant policies, guideline and regulations to assess dynamic regulatory landscape across the industry.
- Work with cross functional teams like ‘Data Analytics’ to improve the processes in relation to data mining, analysis and reporting.
- Hold and manage key accounts in workflow applications to ensure appropriate access is available to execute service deliverables.
- Provide active support during internal and external audits by collecting and presenting the requested data.
- Work together with Lead-Quality Operations and customers to ensure they are kept regularly informed of issues related to the service delivery and elaborate risk mitigation plans, as appropriate.
- Ensure the SOPs, working procedures, process maps, service dashboard, CAPA tracker, order management framework and time sheet is always kept updated for the responsible service area.
- Develop technical training content and impart training to the associates in the responsible service area.
Minimum requirements :
- Graduate / Post graduate in life sciences or pharmacy. MBA in pharmaceutical business will be an advantage.
- English Experience (10-12 years) in QA/Regulatory functions of a pharmaceutical company or Pharma KPO
- Previous experience in delivering GxP (worldwide GMP, GCP, GLP, PV & IT compliance) and regulatory intelligence is preferred Strong project management, analytical, investigative and presentation skills
