CMC Regulatory Specialist

Novo Nordisk

CMC Regulatory Specialist managing complex regulatory submissions for Novo Nordisk's medicines. Navigating regulatory landscapes and ensuring compliance across major global markets.

Posted 7/24/2026full-timeBangalore • 🇮🇳 IndiaSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in regulatory processes, including the preparation and submission of regulatory files such as MAA, NDA, and BLA, while effectively managing interactions with health authorities. Possesses strong strategic planning and stakeholder management skills to drive alignment and compliance across global markets.

Highest-signal resume keywords

Regulatory SubmissionsRegulatory Strategy DevelopmentStakeholder ManagementRegulatory Science KnowledgeFluency in English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRegulatory Strategy DevelopmentRegulatory IntelligenceMAA/NDA/BLA PreparationHealth Authority InteractionsLife Cycle ManagementCMC DevelopmentPost-Approval ChangesDevice Files PreparationSite Master Files Management

Soft Skills

Strategic MindsetPlanning and CoordinationNegotiation SkillsComplex Task StructuringDriving Alignment

Industry Keywords

Regulatory AffairsGlobal MarketsEU RegulationsUS RegulationsChina RegulationsJapan RegulationsDrug DevelopmentRegulatory ComplianceInnovation ProjectsAmbitious Goals

About the role

Key responsibilities & impact

Take ownership of complex regulatory processes that directly enable Novo Nordisk's medicines to reach patients worldwide.
Navigate diverse regulatory landscapes and drive submissions across major markets.
Regulatory submissions to health authorities worldwide.
Lead submission planning by applying regulatory intelligence and developing robust regulatory strategies across global markets.
Prepare, maintain and submit regulatory files including MAA/NDA/BLA, NBOp, CE, CTA/IND, device files, site master files, renewals, post-approval changes and commitments.
Respond to questions from health authorities and manage ongoing interactions with affiliates to ensure alignment and compliance.
Plan and conduct regulatory interactions with health authorities, including preparation of meeting requests, meeting packages, rehearsals and formal meeting minutes.
Provide strategic input to affiliates in preparation for health authority interactions.
Represent the Regulatory Affairs function in RA matrix teams, ensuring alignment of planning and strategy across areas.
Drive innovation and optimisation projects within the regulatory space.

Requirements

What you’ll need

A Master's degree with typically more than 12 years of relevant experience, or a PhD with typically more than 5 years of relevant experience across several regulatory disciplines.
A Bachelor's degree with a minimum of 10 years of relevant experience across several qualifiers may also be considered.
Solid knowledge of regulatory science and requirements across major markets (EU, US, China, Japan), with experience spanning areas such as early- and late-stage drug development, life cycle management, health authority interactions and CMC development.
Strong strategic mindset with proven ability to translate regulatory strategies into ambitious goals, handle ambiguity and make bold, well-informed decisions in complex stakeholder landscapes.
Excellent planning, coordination and stakeholder management skills, with the ability to structure complex tasks, eliminate unnecessary complexity and drive alignment across functions and cultures.
Fluency in written and spoken English, combined with proven negotiation skills and the ability to represent Novo Nordisk at an international level of expertise.

Benefits

Comp & perks

Opportunities to learn and develop
Health insurance
Retirement plans