Novo Nordisk Regulatory Professional Job – Online Application Process
Novo Nordisk Regulatory Professional Job – Online Application Process. MSc Life Sciences Jobs. Life Sciences Regulatory Professional II Vacancy. Interested and eligible applicants can check out all of the details on the same below
Name of the Post – Regulatory Professional II
Location – Bangalore, India
Job category – Regulatory
We are looking for a potential candidate in our Regulatory CMC Insulin unit with experience in Biologics Regulatory Affairs, Knowledge of Manufacturing processes of Biological products, Knowledge of LCM of Biologics, Exposure to handling GMP audits, Exposure in Dealing with HA’s directly, Ensuring Business continuity by securing timely approvals. The position is based in Bangalore.
About the department
Global Regulatory Affairs (GRA) in Global Business Services (GBS) Bangalore is a global RA hub consisting of 8 strong teams of high calibre regulatory professionals. The objective of the team is to offer core Regulatory Affairs (RA) competencies enabling Novo Nordisk (NN) to secure fast, high-quality product approvals.
The team delivers full strategic and operational support on a global scale across the value chain on core regulatory processes across the NN product portfolio. We provide regulatory expertise and work very closely with our colleaguesin RAHQ, Denmark (DK) as well as colleagues in our affiliates all over the world.
As a CMC professional, you will be responsible for regulatory submissions and regulatory interactions with Health Authorities (HAs) worldwide. Your core responsibility will be to establish and maintain the Chemistry Manufacturing and Controls (CMC)/Device part of the regulatory file. 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.
Further, you will be engaging in maintaining the marketing authorization: renewals, annual reports, post-approval changes, CTA/IND amendments, meeting requests and meeting packages. 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.
Will be supporting the post-approval activities. Applying intelligence and developing regulatory strategies. Accountable for maintaining the regulatory tools UpToDate and compliance.
Will be responsible for planning and conducting regulatory interactions with health authorities including preparation of meeting requests, meeting packages, rehearsal and taking minutes of formal meetings.
In addition to the above, you will be responsible for identifying and developing better practices and creating improvements in methods, processes and approaches related to regulatory documentation and strategies.
This position requires you to be highly self-motivated, proactive, organised and have excellent stakeholder management, and communication skills. Ensure quality of submissions by complying to procedures and systems.
- Master of Science (Life Sciences) and/or PhD or Bachelor (Life Sciences)
- 3-5 years of experience in the pharmaceutical industry in Regulatory Affairs
- Experience in working for US FDA, European Union, Japan, China, Australia and ROW markets
- Good communication skills
- Good understanding of end-to-end regulatory processes.
- Hands-on experience in Compilation of Registration/ Dossier Sections.
- Handling of Life Cycle Management of Biologics.
- Communicating with HAs with scientific insight and professional authority. Competence in decision making, as well as flexibility and excellent cooperation in an international environment
- Highly proactive and able to take initiatives
How to Apply
To submit your application, please upload your CV online (click on Apply and follow the instructions).
Deadline – 30 May 2022
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