Associate Regulatory Professional II

Category:  Regulatory
Location: 

Bangalore, Karnataka, IN

   

Do you want a chance to really make a difference? Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference. At Novo Nordisk, we create value by putting patients first. Novo Nordisk Global Business Services – “Global Regulatory Affairs” is looking for Regulatory Professionals with expertise in the area of Medical Devices (Class I and II) to work in Life Cycle Management team. 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 9 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 Regulatory Professional, you will be responsible for planning, preparing and submitting high quality files to the authorities for achieving fast approvals. Furthermore, to influence NovoNordisk’s position within device area and to communicate these within the organisation. You will be acting as an ambassador for assigned medical devices.

 

You will be responsible for planning, coordinating and executing the regulatory tasks as required for existing device products in accordance with the Global Regulatory Device Strategy for the defined area of responsibility in collaboration with manager and colleagues.

 

You will be preparing and compiling the individual sections of all technical files for the defined area of responsibility for faster approval. Compiling, reviewing and submitting pre- meeting packages for authority meetings. Further, handling change requests, non-conformities and corrective action & preventive action. Additionally, you will be reviewing the device documentation, protocols and reports. Assess the appropriateness of scientific documentation.

 

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/technology) and/or PhD with typically some relevant working experience or Bachelor (life Sciences/technology) with relevant experience or equivalent knowledge through relevant practical experience.
  • Above 6 years of experience in pharmaceutical industry in Regulatory Affairs Medical Device expertise (Class I and II, combination products)
  • Experience in preparing and maintenance of Medical Device Technical Files.
  • Knowledge on CTD requirements for Combination Products/Devices with knowledge on ISO13485, MDSAP Requirements, 510(K), CE marking process for medical devices
  • Experience in handling LCM of Medical Devices in European Union, United States, Japan and China.
  • Possess a good communication skills including communication and presentation of ambiguous and complex data
  • Communicating with Notified Bodies/ HAs with technical/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

If you have questions about the position, you are welcome to reach out to KYXB@novonordisk.com

 

Deadline

2 June 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.