Senior Regulatory Affairs Professional

Novo Nordisk India Pvt Ltd; Bengaluru; Sur place; INR 4 000 000 - 7 000 000; Plein temps

Résumé du poste

Novo Nordisk India Pvt Ltd is seeking a Sr Regulatory Professional to lead regulatory strategy, global submissions and lifecycle management for product development and commercialization. The role involves Health Authority interactions, labeling, and driving regulatory activities across cross-functional teams.

We seek an experienced professional with 12–15+ years in regulatory affairs, strong leadership, and deep knowledge of EU, US, China and Japan regulations, and excellent English

Qualifications

• Degree in Pharmacy or related life sciences.
• 12–15+ years in regulatory affairs.
• Hands-on submission experience in EU, US, China and Japan markets.
• Lifecycle management and label development knowledge.
• Strong project management and cross-functional collaboration.
• Proficient written and spoken English.

Responsabilités

• Global regulatory submissions: plan strategy, manage submission plans and regulatory files.
• Health Authority interactions: plan meetings and prepare packages, minutes.
• Core labelling: develop regulatory labels and ensure lifecycle labelling alignment.
• Regulatory lead in Global Project Team: drive regulatory activities across teams.
• Regulatory Affairs clinical expert: provide regulatory input to clinical groups globally.
• Global Regulatory Lead: oversee regulatory strategies for commercial products and lifecycle activities.

Connaissances

Regulatory strategy

Health Authority negotiations

Global submissions

Project management

Stakeholder management

English proficiency

Leadership

Decision making

Formation

B.Pharm/M.Pharm/Life Science

Description du poste

Sr Regulatory Professional Job Title: Sr Regulatory Professional Department: Regulatory Affairs, Research & Development Location: Novo Nordisk Global Business Services (GBS), Bangalore

Your impact begins here As Sr Regulatory Professional, you will lead the regulatory strategy that moves Novo products through development, approval and lifecycle management worldwide. You will own submissions and Health Authority interactions, shape core labelling that reflects what makes a product different, and represent Regulatory Affairs in the Global Project Team. Your decisions will help determine how quickly and clearly new treatments reach people living with serious chronic diseases, and how reliably they stay available.

What you’ll bring

You are an experienced regulatory professional who can set strategy, negotiate with Health Authorities and keep complex global projects moving.

You will bring:

• A degree in Pharmacy (B.Pharm/M.Pharm/Life Science) or a related scientific discipline.
• 12–15+ years of experience in regulatory affairs or closely related areas across the pharmaceutical R&D value chain.
• In-depth knowledge of regulatory science and requirements in the EU, US, China and Japan, as well as other regions, including hands‑on submission experience in these markets.
• Proven experience in lifecycle management, label development, Health Authority interactions, device development and regulatory intelligence.
• Strong project management skills and the ability to simplify complex work for yourself and others.
• Strong negotiation, stakeholder management and networking skills, with the ability to build trust across functions and cultures.
• A thorough understanding of the therapy area, which you use to lead and guide decisions.
• Proficiency in written and spoken English.
• You take personal leadership, adapt quickly when priorities change, spot problems early and make bold, well-founded decisions.
• You welcome honest feedback and enjoy helping others grow.

What you’ll do

The role spans six areas, from global submissions and labelling to project leadership and commercial lifecycle management.

• Global regulatory submissions: Plan regulatory strategy using regulatory intelligence, maintain the submission plan in Vault RIM, and drive regulatory files – including MAA/NDA/BLA, CTA/IND, device files, PIP/PSP, DSUR/PSUR/RMP, renewals and post-approval changes – from preparation and publishing to Health Authority responses, approval and archiving.
• Health Authority interactions: Plan and conduct formal meetings with Health Authorities, from meeting requests and meeting packages to rehearsals and minutes.
• Core labelling: Link the key differentiators in the Target Product Profile to the target Company Core Data Sheet (tCCDS) and to regulatory and market access requirements. Develop tCCDS/CCDS, EU and national labelling for new products, support US labelling and maintain labelling across the lifecycle.
• Regulatory lead in the Global Project Team: Drive all regulatory activities in the Global Project Team and help shape the development path presented to governance. As Chair of the RQC Matrix Team, you set the agenda, prepare input for GPT, GRPT and GRB, and keep information flowing from CMC, device and labelling sub‑teams.
• Regulatory Affairs clinical expert: Bring regulatory expertise to cross‑functional clinical expert groups, including for China, and take responsibility for the worldwide NDA roll‑out.
• Global Regulatory Lead: Own regulatory strategies for commercial products – including label changes, licence maintenance and other lifecycle activities – in line with the Novo Global Project Framework. You will also step in for other Global Regulatory Leads when needed.

Who you’ll work with

You will join Regulatory Affairs in Research & Development, where colleagues help advance scientific ideas towards clinical testing, approval and the people who need them. You would join the RA Diabetes team under Madhusudana Reddy S Your closest partners will be the Global Project Team and the RQC Matrix Team you chair, including CMC, device and labelling specialists.

Externally, you will be a key point of contact for Health Authorities worldwide, including in the EU, US, China and Japan. In this role, you create clarity across functions: flagging progress, risks and issues early, so teams can decide and move forward at pace.

What you can expect here

You will work at the centre of global development and lifecycle decisions, building new skills across the R&D value chain through work with functions and Health Authorities around the world. You will be trusted to own your development and make your voice heard in the decisions that shape each project. You will also help others be their best – onboarding, job-shadowing and mentoring new colleagues, and contributing to team and department engagement.

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

Experience Level

Senior Level