Regulatory Professional I

Category:  Regulatory
Location: 

Bangalore, Karnataka, IN

   

“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 RA Clinical GBS Diabetes & Obesity, GRA unit. Will be responsible day-to day operations with some impact on others within or outside the unit. Works on problems of limited scope according to main job tasks as agreed. Follow standard practices and procedures in analyzing situations or data from which answers can be readily obtained. The position is based in Bangalore.

 

The position
A Regulatory Professional, will Demonstrate some subject matter knowledge. Set and achieve day-to-day operations with some impact on others within or outside the unit. Works on problems of limited scope according to main job tasks as agreed. Follows standard practices and procedures in analysing situations or data from which answers can be readily obtained. Normally receives general instructions on routine work and detailed instructions on new projects or assignments. Might require guidance from senior colleagues / manager for task execution. Limited level of decision making.

 

Key responsibilities

  • Support and provide input to all regulatory submissions to Health Authorities worldwide 
  • Support and provide input to regulatory interactions with Health Authorities
  • Establish and maintain core labelling
  • A flexible attitude and continuous commitment to keep management informed about any unforeseen issues which may influence regulatory compliance, company politics or resource allocation is of importance.
  • Required to identify problems and update or modify working methods in own role with some or few defined procedures, if required seek adequate guidance from peers & Manager.
  • Show a mindset of willingness to adjust to new situations in a continuously changing environment.
  • Few tasks are expected to be carried out independently and with limited supervision as well as a high degree of responsibility and initiative is expected.
  • The position has global impact and requires efficient collaboration and communication with many different professional disciplines. Awareness of cultural differences and understanding of business in different regions is required.
  • Exposure in Clinical Research & Trials is mandatory.
     

This position requires you to be highly self-motivated, proactive, organised and have excellent stakeholder management, communication skills.

 

Qualifications
Below are the required skills.

  • Master of Science (life sciences) and/or PhD or Bachelor (life sciences)
  • 5+ years of work experience within some of the relevant Regulatory Affair’s qualifiers or other key qualifiers as listed above
  • Good communication and some negotiation skills required – i.e., reaching agreement through flexibility and compromise or convincing others with a mutual interest of new concepts, practices, and idea.
  • Submission of regulatory files, response to health authorities and maintenance of marketing authorisations worldwide:
  • Experience in MAA/NDA/BLA, PIP including modifications, commitments, Pharmacovigilance documents (DSUR, PSUR, RMP) verticals.
  • Support Renewals and post approval Changes
  • Support and provide input to the development of the text for CCDS, European Labelling including national labelling for our products. Support US labelling development
  • Support and provide input to the development/maintenance of the label throughout Life Cycle Management

 

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

7th July, 2022

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.