Senior Regulatory Professional/Associate Specialist

Novo Nordisk

Sr Regulatory Professional at Novo Nordisk managing regulatory strategies and submissions across global markets. Collaborating with stakeholders to ensure compliance and efficiency in reaching patients.

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

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategies and submissions, including MAA/NDA/BLA and CTA/IND, while effectively managing interactions with health authorities and cross-functional teams. Possesses strong regulatory science knowledge across key markets and the ability to navigate complex regulatory environments.

Highest-signal resume keywords

Regulatory Strategy DevelopmentRegulatory Submissions ManagementRegulatory Intelligence ApplicationRegulatory Science KnowledgeInterpersonal Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRegulatory IntelligenceLabel DevelopmentRegulatory Requirements AssessmentManufacturing Facility Compliance

Soft Skills

Strategic MindsetInterpersonal SkillsCollaboration

Industry Keywords

MAANDABLACTAINDEU RegulationsUS RegulationsChina RegulationsJapan RegulationsRegulatory Affairs

About the role

Key responsibilities & impact

Take ownership of regulatory strategies and submissions across global markets
Lead submission planning by applying regulatory intelligence and developing robust regulatory strategies
Prepare, submit, and maintain regulatory files including MAA/NDA/BLA, CTA/IND
Respond to questions from health authorities and maintain marketing authorisations globally
Manage interactions with affiliates to ensure aligned and timely execution
Plan and conduct regulatory interactions with health authorities
Represent the Regulatory Affairs function in the RA matrix team
Drive effective information flow to the matrix team to support decision-making
Be accountable for the overall RA CMC/Device regulatory strategy
Align with Product Supply, affiliates, and GRL for timely progress of activities
Inform Line of Business about business-critical decisions

Requirements

What you’ll need

A Master's degree with typically 5–7 years of relevant experience, or a PhD with typically 3–4 years of relevant experience
If you hold a Bachelor's degree, typically 7–9 years of relevant experience is expected
Solid knowledge of regulatory science and requirements across key markets (EU, US, China, Japan)
Experience with regulatory submissions, label development, regulatory intelligence, or device development
Demonstrated experience assessing and managing regulatory requirements and impacts related to manufacturing facilities
A strategic mindset with the ability to navigate ambiguity
Strong interpersonal skills with the ability to collaborate openly across functions
Fluency in written and spoken English.

Benefits

Comp & perks

Opportunities to learn and develop
Health insurance
Wellness programs