15 Aug
|
Novo Nordisk
|
Bengaluru
15 Aug
Novo Nordisk
Bengaluru
Company: Novo Nordisk Global Business Services (GBS)
Job Level: 6
Are you passionate about bringing innovative treatments to patients around the world?
Do you want to play a key role in shaping global regulatory strategies for products that can change the lives of people living with obesity, cardiometabolic and Rare diseases? If so, you could be our next Regulatory Professional II at Novo Nordisk.
Your new role
As a Regulatory Qualified II in Rare Endocrine Diorders team, you will contribute by execution of global regulatory strategies across the product lifecycle. You will support regulatory submissions, health authority interactions, and labelling activities while collaborating with cross-functional teams across Research & Development and global markets.
You will work closely with colleagues across Regulatory Affairs, Clinical Operations, Global Safety, Medical Affairs, Quality, Legal, and other functions to ensure high-quality regulatory deliverables that support successful product development and lifecycle management.
As a Regulatory Professional II, You Will
Support the planning, preparation, and submission of regulatory dossiers to health authorities globally.
Contribute to execute regulatory strategies and submission planning for key development and lifecycle management activities.
Support interactions with health authorities, including preparation of meeting packages, briefing documents, and meeting minutes.
Assist in the development and maintenance of core labelling documents, including CCDS, European labelling, and US labelling.
Support regulatory activities related to marketing authorisations, renewals, post-approval changes, paediatric submissions, and pharmacovigilance documentation.
Collaborate with global cross-functional stakeholders to ensure compliant and timely regulatory deliverables.
Contribute to continuous improvement initiatives and identify new ways of conducting regulatory business.
Support onboarding, mentoring, and knowledge sh
📌 Regulatory Professional II (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru