Novo Nordisk job vacancy for Senior Regulatory Professional | Apply Now

Senior Regulatory Professional

Category: Reg Affairs & Safety Pharmacovigilance
Location: Bangalore, Karnataka, IN

Department: Submission Management BLR

Would you like to join Submission Management BLR, Global Regulatory Affairs and become part of a dynamic and exciting organisation where engaged people work with new technologies and diverse therapeutic areas to bring innovative medicines to patients? Do you want to manage eCTD submissions to obtain Marketing Authorisations for Novo Nordisk’s innovative medicines across the globe? Apply today and join us for a life-changing career.

The Position

Your main task will be to manage and publish eCTD submissions in cooperation with the regulatory teams.

In addition, you will also be managing and publishing roll-out and lifecycle eCTD submissions and contribute to our continuous improvement of our publishing processes and support to our colleagues and stakeholders.

You have a good understanding of the evolving eSubmission standards, and will ensure that we always deliver efficient, timely and compliant submissions to the regulatory agencies.

You will work in a fast-paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration, and the challenges of international communication will be part of your busy workday.

You will be expected to make an impact, to ask questions, and to challenge the status quo to ensure continuous improvements, visionary systems, and services.

Qualifications

To be successful in this role, we expect that you have:

Master’s degree within life sciences.
5+ years of relevant working experience within Regulatory Operations or Regulatory Affairs.
Extensive knowledge about eCTD publishing and document management
Good project management skills and strong written and verbal communication skills in English.

As a person you are a team player who maintains customer focus even when delivering submissions under sometimes tough circumstances. You are open to flexible working hours to accommodate other time zones when needed. You are well organised and analytical with solid problem-solving capabilities, just as you show a winning and positive attitude, and never lose your strategic focus. You can keep your spirits high even under pressure, and as a skilled communicator you can cooperate at any organisational level.

Contact

If you believe you are a match for the above requirements and are highly motivated to take up the role, please apply here with our online application tool.

Deadline

Apply on or before: 16 November 2023

APPLY NOW