Novartis Specialist Jobs

Novartis Specialist Jobs – Life Sciences Candidates Apply Online

Life Sciences candidates apply online for a Specialist position that is available at Novartis. Specialist jobs for life sciences candidates. Novartis is hiring life sciences candidates for a Specialist vacancy as per the details below in their Research & Development area:

Job Title: Specialist

- Advertisement -

Job ID: 270417BR

Location: Hyderabad, IN

Division: SANDOZ

Business Unit: Product Dev SZ

Employment Type: Regular

Job Description Your responsibilities:

Job Description.

Position Purpose.

Ensure preparation, validation, send off and submission of compliant as well as high-quality initial, 2nd wave and upkeep Regulatory filings according to submission plans. Update particular Regulatory systems for Registration Management, Publishing and Document Management. Support the Global Regulatory teams during the product development stage and also provide input as appropriate. Comply with Regulatory procedures and also timelines.

Major Accountabilities

  1. Support regulatory teams during the submission process in all administrative as well as technological steps according to global procedures
  2. Prepare and dispatch/submit documentation packages for predefined submission types and region( s) in compliance with Health Authority requirements
  3. Ensure eCTD lifecycle maintenance according to ICH and regional specifications
  4. Ensure timely update of submission data in the regulatory info management data-bases as well as verify that the data is kept compliant
  5. Be associated with the timely and also reliable processing of regulatory, submission-relevant documents like M1, eApplication Form, COPPs, GMP Certificates 6. Maintain communication network with regulatory features like RCCs, MRCc and also nation organizations as well as non-regulatory stakeholders according to guidance documents
  6. Ensure escalation procedures are followed in case of problems as well as delays
  7. May be associated with document prep work activities like scanning, bookmarking, linking as well as various other activities to ensue document submission readiness
  8. Might be associated with document bulk upload activities.

Key Performance Indicator:

  1. KPIs like on-time filing dispatch/submission, submission rejection rate, customer satisfaction (e.g. regulatory proficiency, responsiveness)
  2. All designated project deliverables fulfil targets for top quality, productivity in compliance with Regula-tory and/ or wellness authorities demands
  3. Delays in launches and also supply caused by GRA (None)
  4. Regulatory compliance.

Minimum requirements:

  • University or College Degree in any field or life science with relevant industry experience or similar degree Good communication in English (oral and written).
  • At a minimum of 2 years’ experience in the Pharmaceutical area, particularly in Regulatory Operations
  • Experience in the Regulatory submission publishing, area is preferred
  • Knowledge of Regulatory standards for the areas mentioned above
  • Organizational awareness and experience working cross-functionally and also in worldwide teams is a plus Ability to work under pressure, showing initiative and flexibility
  • High level understanding of Regulatory quality, criteria and policies.
  • Attention to detail and also quality focused
  • Team-minded.

Apply Online

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