M Pharma Regulatory Affair Analyst @ Novo Nordisk

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M Pharma Regulatory Affair Analyst @ Novo Nordisk

M Pharma Regulatory Affair Analyst @ Novo Nordisk

M Pharma Regulatory Affair Analyst @ Novo Nordisk. Career @ Novo Nordisk. M Pharma & Medicinal chemistry candidates can apply for this job post. Check out all the details on the same below:

Job Title: Regulatory Affairs Analyst

Work Location: Banglore

Eligibility: postgraduate education in science (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life sciences) and experience in working with Regulatory Affairs.

About the department

The GSC Submission Management department was established in 2010, with the purpose of delivering high-quality registration dossiers to our affiliates worldwide.

The main focus area of our department is to provide a superior service to our stakeholders consistently and add value to our submission processes in terms of standardization and efficiency.

 

The Job

As RA Analyst, you will be responsible for compiling and publishing the submission of the Marketing Authorisation Application (MAA)/Lifecycle Management application to European Health Authorities. The key responsibilities are:

  • Facilitation of submission planning meetings with RA colleagues from Product portfolio as well as the Submission Management coordinator from RAHQ Denmark
  • Compilation of dossier based on  TOCs  provided by RA HQ in eCTD format
  • Publishing the dossier & perform post-publishing activities
  • Add navigation elements like hyperlinks, Bookmarks
  • Perform validation of submission
  • Troubleshoot validation error
  • Upload submission in EMA Gateway 

Candidate is  Responsible for delivering high-quality registration dossiers, which require a good understanding of Regulatory guidelines, Administrative, CMC, Non-Clinical & Clinical documentation, different registration file formats (Centralised procedure, Mutual Recognition procedure, Decentralised procedure & National Procedure for EU) and the Regulatory dossier publishing process. Hands on experience in publishing tools like Lorenz Docubridge, Liquent Insight, ISI Publishing, ISI Tool Box, Adobe Acrobat, etc. Hands on experience in validation tool like EURS, Lorenz, etc. Experience in xml editing & Document Management system is preferable. Exposure to e-submission gateways are mandatory.

Apply Online

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