Regulatory Associate

2 months ago

Bengaluru, India Novo Nordisk Full time

**Department: Clinical Medical Regulatory (CMR)**

Do you want to be a part of a high performing team in Novo Nordisk that plays a critical role in driving the success of the business? Do you have what it takes: the right drive, a sharp mind, customer orientation, openness and focus on what matters and a genuine interest in working with people? If you find challenges inspiring and want to drive innovation within a multifaceted and inspiring working environment, you may be our new RA Associate for the Clinical Medical Regulatory team based at Bangalore.

**The Position**

This role requires someone to secure regulatory approvals of New Products, Clinical Trials, Medical Device &Variation submission for existing products to maintain the existing license in due time, for Novo Nordisk products in business areas. As a RA Associate you will be responsible to:

- Perform QC (Quality Control) of HA (Health Authority) submission dossier prior to the submission.
- Proactively identify the potential queries from HA and share with relevant Medical, Commercial, CDC Trial managers and HQ RA CTA (Clinical Trial Applications) management team
- Complete HA submission as per agreed timelines
- Actively manage notification of the study status, renewal of the import licenses, annual updates of the study, protocol amendment, addition of the sites and other relevant correspondences required for the conduct of the clinical trial.
- Secure regulatory approvals of clinical trials, new products & Medical device as per agreed timelines, for Novo Nordisk projects.

**Qualifications**
- B. Pharmacy, M.Pharm, Pharm-D, M.sc
- 4-6 years of experience in the pharmaceutical industry.
- Knowledge of Indian Drug Regulations (D&C Acy, MCMR, ICH etc.). Regulatory Affairs processes and relevant strategies, Clinical research procedures and GCP requirements.

**About the department**

Novo Nordisk India affiliate office is in Bangalore & has more than 1,400 people working across the country in various functions. The RA Associate position is based in Bengaluru and reports to the Associate Manager RA.

**Working at Novo Nordisk**

Working at Novo Nordisk is never just a job. It’s the opportunity for a life-changing career. For over 100 years, Novo Nordisk has pioneered many therapeutic breakthroughs in Diabetes, Obesity, Haemophilia and Growth Hormone Disorders. As an employee at Novo Nordisk, you have the potential to make a difference to both people and society. By improving treatment, we will not only keep people healthy and productive, but also help their families and their communities.

**Contact**

**Deadline**

1st May 2023.

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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