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Senior Executive, Global Regulatory Strategy And Intelligence

Sun Pharma
3-5 years
Not Disclosed
Gurgaon, Gurugram, India
10 May 21, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICD-10 CM, CPT, HCPCS Coding, 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

Senior Executive – Global Regulatory Strategy & Intelligence

Global Regulatory Affairs (Specialty Business – Brands & Innovative Medicines)

Location: Gurgaon
Company: Sun Pharmaceutical Industries Ltd


Role Overview

The Senior Executive – Global Regulatory Strategy & Intelligence supports regulatory intelligence activities that guide global regulatory strategy, competitive positioning, and submission planning.

This role focuses on:

  • Monitoring global regulatory environments

  • Analyzing competitor regulatory strategies

  • Supporting regulatory submissions (Module 1 focus)

  • Providing strategic insights to internal teams


Key Responsibilities

1. Regulatory Intelligence & Landscape Monitoring

  • Collect and analyze regulatory intelligence across countries and regions

  • Collaborate with country SMEs to map local regulatory frameworks

  • Track evolving guidelines from global health authorities:

    • FDA

    • EMA

    • PMDA

    • NMPA

  • Maintain updated regulatory knowledge databases


2. Regulatory Trend Analysis

  • Monitor updates in:

    • Regulatory policies

    • Guidelines and directives

    • Approval pathways

  • Identify regulatory implications for internal products and pipelines

  • Prepare internal reports and intelligence summaries


3. Competitive Intelligence

  • Track competitor:

    • Approvals

    • Submission strategies

    • Regulatory pathways

  • Perform benchmarking and gap analysis

  • Identify regulatory precedents to guide internal strategy


4. Regulatory Strategy Support

  • Support preparation of regulatory strategy documents

  • Assist in defining non-clinical and clinical regulatory approaches

  • Contribute to early regulatory planning for pipeline and marketed products


5. Submission Support (Module 1 Focus)

  • Assist in preparation and review of:

    • Module 1 regulatory components

  • Ensure compliance with country-specific submission requirements

  • Support regulatory documentation consistency across regions


6. Compliance & Tracking

  • Track submission timelines

  • Ensure regulatory compliance across regions

  • Maintain internal regulatory intelligence repositories


7. Cross-Functional Collaboration

  • Work closely with:

    • Regulatory Affairs teams

    • Country regulatory SMEs

    • Clinical and non-clinical teams

  • Support strategic decision-making through regulatory insights


Required Qualifications

Education

  • Master’s degree in:

    • Life Sciences

    • Pharmacy

    • Pharmacology

    • Chemistry

    • Related discipline


Experience

  • 3–5 years in:

    • Pharmaceutical industry OR biotechnology industry

  • Preferred exposure:

    • Regulatory Affairs

    • Regulatory Intelligence

    • Competitive Intelligence


Technical Skills

  • Understanding of global regulatory frameworks

  • Knowledge of:

    • Drug approval pathways

    • Regulatory submission structure (Module 1–5 awareness)

  • Ability to interpret:

    • Regulatory updates

    • Policy changes

    • Health authority guidelines

  • Experience with regulatory documentation and reporting


Key Competencies

Analytical Skills

  • Ability to analyze regulatory trends

  • Competitive benchmarking

  • Gap identification in regulatory strategies

Communication Skills

  • Strong written reporting ability

  • Ability to summarize complex regulatory information clearly

  • Presentation of insights to internal stakeholders

Behavioral Skills

  • Attention to detail

  • Proactive intelligence gathering

  • Strong collaboration with cross-functional teams

  • Strategic thinking mindset

  • Ability to work in fast-changing regulatory environments


Role Summary (Simple View)

This role is mainly about:

  • Tracking global drug regulations

  • Studying competitor approvals and strategies

  • Supporting regulatory submission planning (especially Module 1)

  • Turning regulatory updates into actionable insights


Position Context

Sun Pharmaceutical Industries Ltd uses this function to strengthen:

  • Global regulatory intelligence systems

  • Faster and more compliant submissions

  • Strategic alignment between regulatory, clinical, and R&D teams