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: Regulatory Publisher
Job Description:
Seeking for Regulatory Professionals with 1 + year Experience. Great opportunity to obtain global working experience.
Company Summary
An exciting opportunity has arisen for a Regulatory Publisher to join an international healthcare company, one of the market leaders in their field. The Research and Development pipeline of Novartis Vaccines is recognized as being one of best in the industry and offers the potential for significant growth to one of the fastest expanding global vaccines business. This position will be exclusively dedicated to vaccine Development, based in Hyderabad and which will offer a unique opportunity to work within international teams in the frontline of developing innovative global public health solutions.
Key Responsibilities and Duties
The Regulatory Submission Publisher is responsible for the compilation, publishing, and technical quality control of Regulatory submissions including technical troubleshooting to ensure issues with submissions are resolved and deadlines met.
Produces high-quality dossiers by handling the collection of components, publishing / assembly, quality review, and delivery of submissions in paper and electronic format (like NeES, eCTD..Etc.). For paper submissions, creates cross-references, table of content, tab / slip-sheets, and volumes. For electronic submissions, performs bookmarking, hyper-linking, and tables of content creation according to Health Authority (HA) guidelines.
Publishes Regulatory documents with state-of-the-art software applications in the Novartis Development environment according to internal processes and agreed-upon timeline.
Performs technical quality control of published submissions before release to the HAs and / or Headquarters. This involves detailed verification of paper and / or electronic components to ensure compliance with HA regulations.
Liaise with counterpart and applicable line functions (e.g., Toxicology, Clinical) for problem solving. Shares accountability with different Regulatory Affairs contact points to ensure proper organization of a timely submission. Proactively trouble-shoots technical/quality issues relating to the preparation and dispatch of submissions.
Support communication strategy within the Regulatory Global Services group India. Support key processes are in place and functioning efficiently to facilitate teamwork and local communication. Act cross-functionally locally to facilitate Regulatory Affairs Operations related agreements between line Units.
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Candidate Profile:
Education:
- Tertiary qualified – Pharmacy or Science (majoring in a life science or chemistry) with or without postgraduate qualifications
Experience:
An ability to work within a team, communicate effectively across all levels and excellent organizational skills are fundamental in this role. Although you will be working as part of a team and additional support will be available when required, you should have a 'can do' attitude and a practical approach to problem solving.
Knowledge in ICH guidelines, Regulatory Documentation & Regulatory Submissions with experience in eCTD Publishing preferred.
Additional Information:
Location: Hyderabad
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 84580BR
End Date: 19th Sept., 2011
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