Job Summary

Shape global regulatory strategies that bring innovative therapies to patients worldwide. If you thrive on complexity, enjoy building bridges across borders and want your work to directly influence how health authorities view our pipeline this role is for you.

Responsibilities

- As a Regulatory Professional, you will drive regulatory submissions and strategy development across global health authorities, while mentoring colleagues and contributing to the continuous evolution of our regulatory practice. You will work in a dynamic environment where strategic thinking, proactive problem-solving and cross-cultural collaboration come together every day.
- Driving regulatory submissions to health authorities worldwide: lead submission planning, apply regulatory intelligence and develop strategy; drive preparation, maintenance and submission of regulatory files (MAA/NDA/BLA, CTA/IND, Site Master File, renewals, post-approval changes and commitments) and lead interactions with affiliates
- Supporting health authority interactions: contribute to the planning and conduct of regulatory authority interactions, including meeting requests, meeting packages, rehearsals and minutes from formal meetings, and provide input to affiliates preparing for their own health authority engagements
- Representing RA in the matrix team: ensure alignment of planning and strategy across areas and secure a strong information flow between the RA function and the wider matrix team
- Monitoring submissions and handling renewals: drive monitoring of upcoming submissions in Vault RIM, assess national documentation requirements, conduct high-level planning and take responsibility for the overall planning and initiation of global renewals
- Evaluating guidelines and driving innovation: stay ahead of evolving regulatory landscapes and contribute to innovation projects that strengthen how we work
- Mentoring and training colleagues: share your expertise to help others grow and build collective capability within the team

Your Department

In Research Development,



you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs.

You will join a Regulatory Affairs team that sits at the heart of our global development efforts, partnering closely with affiliates, health authorities and cross-functional colleagues to ensure that our therapies reach patients efficiently and safely. Here, your strategic mindset and regulatory expertise will have a tangible impact on the speed and success of our pipeline.

Qualifications

We are looking for a strategic and proactive regulatory professional who brings both technical depth and the cultural awareness needed to navigate a global stakeholder landscape. You'll bring with you:

- Master's degree with 7+ years' relevant working experience within Regulatory Affairs, including solid knowledge of regulatory science and requirements across EU, US, China and Japan
- Proven experience across the drug development lifecycle early- and late-stage development, Life Cycle Management, label development, health authority interactions, device development and regulatory intelligence
- Solid understanding of the RD value chain and broader pharma context, with appreciated additional knowledge in areas such as CMC, project management, drug-device combination products, quality, clinical pharmacology or pharmacovigilance
- A strategic mindset combined with boldness in decision-making, accountability, persistence and the ability to deliver results that have direct impact within and beyond your unit
- Strong communication, mentoring and team skills, an inclusive mindset and the ability to adjust quickly in a continuously developing environment
- Fluency in written and spoken English

Disclaimer : This job posting & Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Regulatory Professional (Karnataka)
🏢 Novo Nordisk
📍 Karnataka