Opportunity for Regulatory Associate | Apply now 2023
Opportunity for Regulatory Associate | Apply now 2023
Category:
Regulatory
Location:
Bangalore, Karnataka, IN
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.
If you have what it takes to be a part of Novo Nordisk team, Apply now!
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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:
- Prepare and compile required documents for New Drugs, Clinical trial application, post approval variations towards HA as per agreed timelines with Medical, Commercial and CDC (Centres for Disease Control and Prevention) Trial managers.
- 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
- All life science graduates are eligible but preference to Mpharma candidates.
- 1-3 years of total exp 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 is a Denmark based multinational with leadership in diabetes. Novo Nordisk India affiliate office is in Bangalore & has more than 1,400 people working across the country in various functions. The position Regulatory Associate (RA) reports directly to the Manager of RA & PV and demands responsibility to manage the clinical and post approval changes to local health authorities, maintain local regulatory environment and ensure compliance to local legislation.
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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
To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions).
Deadline
27th September 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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