Assoc Regulatory Affairs I
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Posted on:
3 hours ago
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1 Vacancy
Job Summary
Department - Regulatory Affairs
Organization Novo Nordisk India Pvt Ltd
Are you passionate about helping bring life-changing medicines and clinical trials to patients by securing timely regulatory approvals Join Novo Nordisk as a Regulatory Affairs Professional and play a key role in supporting submissions and lifecycle activities across India. If you are ready to work in a purpose-driven environment with high standards of ethics and quality read on and apply today for a life-changing career.
Purpose of the job
As an Assoc Regulatory Affairs I you would have to secure timely regulatory approvals for clinical trials new products medical devices and lifecycle variations and maintain existing licenses in due time for Novo Nordisk across India.
Roles & responsibilities
- Prepare compile and submit clinical trial applications and related correspondence to local health authorities.
- Manage trial maintenance activities (e.g. status notifications renewals annual updates protocol amendments site additions import license renewals and other required correspondence).
- Support submissions for new products medical devices and variations for existing products to maintain licenses in due time.
- Receive archive and support evaluation of safety information and lifecycle changes; support internal workflows needed for compliant labelling/artwork implementation.
- Maintain accurate submission records trackers and electronic repositories; ensure timely archiving of submissions and acknowledgements.
- Contribute to regulatory intelligence including updates to local requirements information to keep relevant stakeholders informed.
- Act as a point of contact for selected local authority interactions (e.g. State FDA-related activities) as relevant to the role.
- Ensure all activities are performed in line with company procedures ethical standards and the Novo Nordisk Way.
Education and work requirements
- A bachelors degree in pharmacy (or similar) a Masters degree in Pharmaceutical Regulatory Affairs is considered an advantage.
- At least 2 years of experience within regulatory affairs or a related role in the pharmaceutical industry.
- Knowledge of clinical trial application processes and product lifecycle maintenance activities.
- Strong attention to detail good planning skills and the ability to manage multiple priorities.
- Clear communication skills and a collaborative mindset with commitment to high ethical standards.
About the department
You will join the Regulatory Affairs team supporting Novo Nordisks portfolio across India. Working closely with colleagues across Clinical Medical Quality Legal Supply Chain Sales and Marketing you will help ensure that regulatory submissions and lifecycle activities are delivered with quality and in due time. The team operates in a collaborative environment with a strong focus on compliance continuous improvement and patient safety.
Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes we are growing massively and expanding our commitment reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table and we work continuously to bring out the best in them. Working at Novo Nordisk were working toward something bigger than ourselves and its a collective effort. Join us! Together we go further. Together were life changing.
Contact
To submit your application please upload your CV online (click on Apply and follow the instructions).
Deadline
27th March 2026.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.
Key Skills
About Company
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