Regulatory Professional - Regulatory Affairs

Locations: Bangalore

Department: Regulatory Affairs

Organization: Novo Nordisk Global Business Services (GBS), India.

Are you a motivated regulatory professional with a keen interest in enabling global patient access through highquality regulatory submissions and lifecycle management Join Novo Nordisk Global Business Services as a Regulatory Professional. If you excel at translating complex clinical and regulatory requirements into clear, fitforpurpose submission packages, coordinating stakeholder input across crossfunctional teams, and driving process improvements to enhance submission quality and timeliness, we want to hear from you. Apply now with your latest CV - your next impactful career step could start here.

Your New Role

As a Regulatory Professional, you will support end-to-end lifecycle management activities for regulatory submissions and interactions with global health authorities. Working within the RA Diabetes team, you will help plan and prepare regulatory submissions (MAA/NDA/BLA, CTA/IND, Device Files, Site Master Files, and related documents), support responses to health authorities, maintain marketing authorizations, and contribute to labeling and riskminimization materials. You will participate in submission publishing and distribution, maintain regulatory event records in RIM, and support meeting requests, meeting package preparation, rehearsals and minutetaking for formal regulatory meetings. You will also contribute to process development and optimization projects, stakeholder negotiation and communication, and knowledgesharing to improve submission quality and reduce lead times.

Key responsibilities

• Support preparation, publishing and submission of regulatory files and responses to health authorities worldwide, and assist with maintenance of marketing authorisations and renewals.
• Support planning and conduct of regulatory interactions with authorities, including meeting requests, packages, rehearsals and minutes.
• Contribute to development and maintenance of core labelling (CCDS, regional and national labels) across the product lifecycle.
• Support pharmacovigilance and lifecycle documents (DSUR, PSUR, RMP), post approval changes and commitments.
• Drive and support process updates, system/tool maintenance and optimisation projects to improve efficiency and quality of regulatory deliverables.
• Keep up to date with regulatory requirements and share best practice within the team act as RA representative in cross functional groups as required.
• Provide support for onboarding, mentoring and training of new team members stand in as substitute for more senior RA staff when needed

Your Skills and Qualifications

To be successful in this role, you should have the following qualifications:

• Must have Master of Science or other relevant professional degree required.
• Must have Approximately 6 to 8 years experience in regulatory affairs or related fields, with a solid understanding of clinical regulatory dossiers and the CTD format. Experience with global submissions and regulatory procedures is desirable.
• Must have Familiarity with submission planning and RIM, regulatory dossier preparation (MAA/NDA/BLA, CTA/IND), labelling development and pharmacovigilance documentation.
• Must have Strong communication and stakeholder management skills (written, oral, presentation) ability to negotiate and build consensus across functions and regions. Commitment to quality, adaptability to a changing environment, good planning and organisational skills, and a proactive, team-oriented approach.
• Should have demonstrated ability to evaluate regulatory options, maintain cross functional relationships, share knowledge and suggest process improvements. Cultural awareness and the ability to work effectively across global teams are essential.

Your New Department

You will join RA Diabetes in Global Regulatory Affairs Bangalore, reporting to the Associate Director, RA Diabetes. The department works globally with Clinical Operations, Medical & Science, Global Safety, Global Medical Affairs, Global Marketing/Patient Access, Legal, Quality, RA affiliates and health authorities (FDA, EMA, PMDA and others) to support product development, approvals and lifecycle management. The team focuses on highquality regulatory submissions, continuous improvement of processes, and collaborative crossfunctional engagement to bring safe and effective therapies to patients worldwide.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination, and a constant curiosity. For over 100 years, this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect, and a willingness to go beyond what we know delivers extraordinary results.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

More Information

To submit your application, please upload your CV online (click on Apply and follow the instructions).You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV.

Deadline

15^th April 2026

Disclaimer
Also, it has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've 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 what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're 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.