Senior Regulatory Professional

Novo Nordisk

. Lead regulatory strategy for Novo Nordisk products through development, approval and lifecycle management worldwide .

Posted 10/14/2026full-timeBangalore • IndiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in regulatory strategy, submissions, and lifecycle management for pharmaceutical products across global markets, with a strong focus on Health Authority interactions and label development. Proven ability to lead cross-functional teams and manage complex regulatory projects while ensuring compliance with regional requirements.

Highest-signal resume keywords

Regulatory Affairs LeadershipRegulatory Submissions ExperienceLifecycle Management ExpertiseProject Management SkillsStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentSubmission PreparationLabel DevelopmentRegulatory IntelligenceHealth Authority InteractionsMAA/NDA/BLA ManagementCTA/IND ManagementDevice DevelopmentEU/US/China/Japan Regulatory KnowledgePharmaceutical R&D Experience

Soft Skills

Negotiation SkillsStakeholder ManagementNetworking SkillsTrust BuildingAdaptability

Tools & Technologies

Vault RIM

Certifications & Qualifications

Degree in PharmacyB.Pharm/M.Pharm/Life Science

Industry Keywords

Regulatory SciencePharmaceutical IndustryGlobal Project TeamClinical Expert GroupsTherapy Area Knowledge

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Lead regulatory strategy for Novo Nordisk products through development, approval and lifecycle management worldwide
Own regulatory submissions and Health Authority interactions
Shape core labelling and ensure it reflects product differentiators
Represent Regulatory Affairs in the Global Project Team
Plan regulatory strategy using regulatory intelligence
Maintain the submission plan in Vault RIM
Drive regulatory files, including MAA/NDA/BLA, CTA/IND, device files, PIP/PSP, DSUR/PSUR/RMP, renewals and post-approval changes, from preparation through approval and archiving
Plan and conduct formal Health Authority meetings, including meeting requests, packages, rehearsals and minutes
Develop tCCDS/CCDS, EU and national labelling for new products; support US labelling and maintain labelling across the lifecycle
Drive regulatory activities in the Global Project Team and shape development paths presented to governance
Chair the RQC Matrix Team, set agendas, prepare input for GPT, GRPT and GRB, and coordinate information from CMC, device and labelling sub-teams
Provide regulatory expertise to cross-functional clinical expert groups, including for China
Take responsibility for worldwide NDA roll-out
Own regulatory strategies for commercial products, including label changes, licence maintenance and other lifecycle activities
Step in for other Global Regulatory Leads when needed
Flag progress, risks and issues early so teams can make timely decisions
Support onboarding, job-shadowing, mentoring and team engagement

Requirements

What you’ll need

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
Hands-on submission experience in the EU, US, China and Japan
Proven experience in lifecycle management, label development, Health Authority interactions, device development and regulatory intelligence
Strong project management skills
Strong negotiation, stakeholder management and networking skills
Ability to build trust across functions and cultures
Thorough understanding of the therapy area
Proficiency in written and spoken English
Ability to adapt quickly when priorities change, identify problems early and make well-founded decisions

Benefits

Comp & perks

Inclusive recruitment process and equality of opportunity for all job applicants
Opportunities to build new skills across the R&D value chain
Ownership of professional development
Onboarding, job-shadowing and mentoring opportunities
Contribution to team and department engagement