Regulatory Professional Ii

2 weeks ago

Bengaluru, India Novo Nordisk Full time

**About the department**

Regulatory Affairs play an important role in ensuring that all new Novo Nordisk treatments and devices are developed with compliance and the patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs are involved throughout all phases of product development and roll-out. Our people in Regulatory Affairs come from many different academic and professional backgrounds, bringing valuable insights and expertise to the team and the company to ensure minimum time to market. This makes Regulatory Affairs a truly multi-disciplinary place to work with high professional standards, excellent opportunities for fast-paced professional development and career opportunities.

**The Position**
- Compile, review and submit pre-meeting packages for authority meetings.
- Handle post approvals, query response, change requests from QA.
- Submission of regulatory files, response to health authorities and maintenance of marketing authorizations worldwide.
- Handle Life Cycle Management (LCM) of the product, keeping the product live
- clinical file protocols and Interim study reports.

**Qualifications**
- 6 years+ of experience in Regulatory affairs (within CMC/NDA/Clinicals) related field along with Graduate or Post graduate degree is required.
- Experience in handling health authorities/government bodies/local market authorities is must.
- Experience in handling life cycle management of product is required.
- Global exposure in terms of handling different markets.
- Excellent communication and presentation skills.
- Bold and strong personality with proven negotiation skills (Should be able to convince and put forward the facts confidently)
- Self-managed, strong personal drive, team player and ability to engage with colleagues and peers towards delivering excellent performance and results.
- High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones.

**Working At Novo Nordisk**

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales
- we're all working to move the needle on patient care.

**Contact**

**Deadline**

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.

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