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Regulatory Professional Ii - Region Eucan

Novo Nordisk
2+ years
Not Disclosed
Bengaluru, India
10 May 26, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Professional II – Region EUCAN

Company: Novo Nordisk
Department: International Operations Regulatory Affairs (IORA) – Bangalore
Location: Bangalore
Category: Regulatory Affairs & Safety Pharmacovigilance
Application Deadline: 04 June 2026


Job Summary

The Regulatory Professional II – Region EUCAN role focuses on supporting country-specific regulatory submissions, approvals, and lifecycle management activities across Europe and Canada markets. The role combines regulatory expertise, stakeholder management, compliance oversight, and strategic coordination with global teams, affiliates, distributors, and health authorities.

The position requires strong knowledge of regulatory processes, regional health authority requirements, and cross-functional collaboration in a multicultural global environment.


Key Responsibilities

1. Regulatory Submission & Approval Management

  • Lead compilation, submission, and approval of country-specific regulatory dossiers for assigned countries.

  • Support submissions related to:

    • New Drug Applications (NDAs)

    • Lifecycle management activities

    • Post-approval changes

  • Ensure submissions meet:

    • Local health authority requirements

    • Regulatory timelines

    • Quality and compliance standards


2. Labeling & Promotional Material Review

  • Review:

    • Product labeling

    • Promotional materials

  • Ensure compliance with:

    • Country-specific regulations

    • Local health authority (HA) requirements

    • Regulatory policies and standards


3. Regulatory Coordination & Query Management

  • Monitor applications through:

    • Distributor review stages

    • Health authority evaluation processes

  • Coordinate responses to:

    • Regulatory queries

    • Deficiency letters

    • Approval-related communications

  • Engage with:

    • Distributors

    • Local authorities

    • Internal stakeholders

to facilitate timely approvals and regulatory compliance.


4. Regulatory Compliance & Environmental Monitoring

  • Monitor changes in local regulatory environments across assigned markets.

  • Ensure ongoing compliance with:

    • Country-specific regulations

    • Health authority expectations

    • Internal regulatory procedures

  • Collaborate closely with local Regulatory Affairs teams.


5. Stakeholder Management & Collaboration

  • Build and maintain strong working relationships with:

    • Global Regulatory Affairs teams

    • Affiliates

    • Distributors

    • Local health authorities

  • Support cross-functional collaboration to ensure:

    • Efficient regulatory execution

    • Alignment on submission strategies

    • Smooth approval processes


About the Department

The International Operations Regulatory Affairs – Bangalore team is an extension of the global IO-SO Regulatory Affairs organization based in:

  • Zurich

  • Copenhagen

The department supports:

  • Fast global product approvals

  • Portfolio integration

  • Regulatory business continuity

  • High-quality regulatory operations across international markets


Required Qualifications

Educational Qualification

  • Postgraduate degree in:

    • Science

    • Pharmacy

    • Life Sciences

    • Related fields


Experience

  • Minimum 6+ years of experience in Regulatory Affairs


Required Skills & Competencies

Regulatory Expertise

  • Strong knowledge of:

    • Pharmaceutical regulatory guidelines

    • Country-specific health authority requirements

    • Multi-market regulatory landscapes

    • End-to-end regulatory processes

  • Ability to identify and articulate regulatory signals effectively.


Stakeholder Management

  • Strong communication and relationship management skills.

  • Ability to collaborate with:

    • Global teams

    • Affiliates

    • Health authorities

    • External partners


Project & Process Management

  • Highly organized and self-managed.

  • Ability to:

    • Take initiative proactively

    • Manage multiple submissions simultaneously

    • Deliver results under timelines


Cross-cultural Collaboration

  • Cultural awareness and adaptability in global working environments.

  • Ability to work effectively in multicultural and geographically distributed teams.


What Novo Nordisk Offers

At Novo Nordisk, employees gain opportunities to:

  • Work on high-impact regulatory projects

  • Contribute to patient access to medicines globally

  • Develop expertise across:

    • Regulatory systems

    • Therapeutic areas

    • International markets

  • Build long-term career growth in a global healthcare organization focused on defeating chronic diseases.