Regulatory Professional II

Category:  Regulatory
Location: 

Bangalore, Karnataka, IN

Regulatory Professional II

“Starting a career at Novo Nordisk is more than getting a job. It is an opportunity to improve the lives of millions of people living with a serious chronic disease. We are a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. Millions rely on us. It is very important to us that anyone working with us feels empowered as an employee and as a person. We all should have the opportunity to act fast, make decisions and be agile.


We are looking for a potential candidate in our Regulatory CMC Insulin unit with experience in Biologics Regulatory Affairs, Knowledge on Manufacturing Process of Biological products, Knowledge on LCM of Biologics, Exposure in handling GMP audits, Exposure in Dealing with HAs directly. 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 team of high calibre regulatory professionals. The objective of the team is to offer core Regulatory Affairs (RA) competencies enabling NovoNordisk (NN) secure fast, high quality product approvals.

The team delivers full strategic and operational support on a global scale across value chain on core regulatory processes across NN product portfolio. We provide regulatory expertise and work very closely with our colleagues in RAHQ, Denmark (DK) as well as colleagues in our affiliates all over the world.

 

The position

As a CMC Regulatory 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 Chemistry Manufacturing and Controls (CMC)/Device part of regulatory file. Defined standard CMC variation applications (e.g. Additional manufacturing site, extension of product shelf life, new cell banks) and manufacturing site submissions, follow-up and approvals.


Further you will be engage in maintaining the marketing authorization: renewals, annual reports, post approval changes, CTA/IND amendments, meeting request and meeting packages. You will be responsible for 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.
You will be supporting the post-approval activities. Applying intelligence and developing regulatory strategies. Creating content plan and maintaining regulatory affairs submission plans in regulatory tools/system.

 

You 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.

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, communication skills. Ensure quality of submissions by complying to procedures and systems.

 

Qualifications

Below are the required skills.

•    Master of Science (life sciences) and/or PhD or Bachelor (life Sciences) 
•    Above 8 years of experience in pharmaceutical industry in Regulatory Affairs
•    Experience in European Union, Japan, China, Australia and Row of the World markets
•    Good communication skills
•    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
 
Working at Novo Nordisk
At Novo Nordisk, we strive for excellence. You share the same passion and commitment as our employees in our journey to make a difference to patients’ lives. In exchange, we offer you the chance of a lifetime to work with extraordinary talent and benefit from unmatched opportunities for professional and personal development.

 

Contact
To submit your application, please upload your CV online (click on Apply and follow the instructions). 

 

Deadline
15 July 2022

Regulatory Professional II