Are you looking for the opportunity to make our patients’ lives better and leave your footprint! Then maybe you are the “Senior Regulatory Professional Chemistry, Manufacturing and Controls (CMC) Biopharm Established Products” we need for an exciting project.

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About the department
Global Regulatory Affairs (GRA) in Bangalore consists of eight departments that work across our global processes and support both colleagues in Head Quarter Denmark (DK) as well as colleagues in our affiliates all over the world. As the area is growing, the total area will by midyear 2019 consist of approximately 120 dedicated employees. Regulatory Operations, Global Business Services (GBS) is an integral part of Regulatory Operations DK. The objective of this team is to ensure efficient and competitive Regulatory Operations to support Regulatory Affairs HQ and RA Affiliates. The team provides services in Submission Management, Regulatory Information Management, and Operational Graphic Design.

Position: Senior Professional II with experience in Regulatory Affairs CMC

Location: Bangalore, Karnataka

Job Description:

  • As a Senior RA professional main function is to plan, prepare, and submit high-quality files to the authorities achieving fast approvals for products within the department area of responsibility.
  • You will be responsible for planning, coordination and executing the regulatory tasks as required in the projects or existing products in accordance with the regulatory strategy for the defined area of responsibility
  • Furthermore, you will be responsible for the preparation and compilation of the individual sections of all files for the defined area of responsibility, in accordance with internal requirements and external regulatory guidelines and regulations.
  • This role requires providing regulatory interaction concerned with scientific issues with affiliates and authorities for all files within the defined area of responsibility and it includes evaluation of the regulatory implications of changes and necessary actions.
  • Additionally, you will be responsible CMC part of the Insulin portfolio, Defined standard CMC variation applications (e.g. Additional manufacturing site, an extension of product shelf life, new cell banks) and manufacturing site submissions, follow-up and approvals.

Desired Candidate Profile:

  • Experience within global Regulatory Affairs CMC. Supplemented with experience from related areas in the pharmaceutical industry e.g. production, product development or production QA.
  • Work experience with European medicines agencies, EMA, and with US FDA.
  • Require analytical mindset, innovative and customer-oriented skills with the ability to focus on detail without losing the overview
  • Focuses on targets and delivering results
  • Assesses and solves problems effectively
  • Ability to work in teams and to collaborate across functions
  • Communicates openly and effectively and negotiates with impact and influence

Qualification: M.Pharma

Experience: 6-8 Years in RA – CMC

Contact Details: For further information, please contact Sudha at zras@novonordisk.com

Last Date to Apply: 20th July 2020

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