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Executive Regulatory Affairs Job at Ferring India

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Ferring Pharmaceuticals Careers has announced a new opening for the position of Senior Executive – Regulatory Affairs in Hyderabad, India. This is an excellent opportunity for experienced Regulatory Affairs professionals with expertise in CDSCO submissions, SUGAM portal filings, dossier preparation, pharmacovigilance, and India regulatory compliance.

Candidates with M.Pharm, MSc, or equivalent Life Sciences qualifications and at least 5 years of industrial experience in Regulatory Affairs are encouraged to apply.

Job Overview

DetailsInformation
Job TitleSenior Executive – Regulatory Affairs
CompanyFerring Pharmaceuticals
LocationHyderabad
DepartmentRegulatory Affairs
Experience RequiredMinimum 5 Years
QualificationM.Pharm / MSc / Equivalent
Employment TypeFull Time
Application DeadlineMay 30, 2026
Job Requisition IDR0037249

Key Responsibilities

Regulatory Submission Activities

The selected candidate will handle regulatory submissions and licensing activities for Central and State regulatory authorities. Responsibilities include:

  • Preparation and submission of:
    • Import Licenses (Form 12 & CT-16)
    • CDSCO NOCs (CT-10, CT-12 & CT-13)
    • Test Licenses (Form-29)
    • CT-21 applications
    • CT-05 BA/BE applications
    • WHO-GMP applications
  • Filing applications through:
    • NSWS portal
    • SUGAM portal
    • ONDLS portal
    • State FDA online systems
  • Coordination with CDSCO, CROs, CMOs, and State FDA authorities

Dossier Preparation & Documentation

  • Prepare and review Marketing Authorization dossiers
  • Review:
    • CMC documents
    • BMRs and COAs
    • Validation protocols
    • Drug Master Files (DMFs)
    • Clinical trial documents
    • Packaging artwork and inserts
  • Ensure compliance with India regulatory guidelines and quality standards

Regulatory Compliance & Query Management

  • Respond to regulatory authority queries
  • Conduct gap analysis and risk assessments
  • Maintain regulatory databases and tracking systems
  • Monitor approvals and registration timelines

Cross-Functional Coordination

  • Collaborate with QA, QC, Manufacturing, Clinical, R&D, and Pharmacovigilance teams
  • Support regulatory strategy for new product development

Pharmacovigilance Activities

  • Perform pharmacovigilance case processing
  • Ensure safety reporting compliance as per regulatory standards

Required Qualifications

Candidates applying for this Regulatory Affairs job in Hyderabad should possess:

  • M.Pharm / MSc / Equivalent in Pharmacy or Life Sciences
  • Minimum 5 years of Regulatory Affairs experience
  • Strong knowledge of:
    • CDSCO regulations
    • India regulatory submissions
    • SUGAM portal
    • NSWS portal
    • WHO-GMP documentation
  • Experience in international market submissions is preferred

Salary & Benefits

The estimated salary for this Senior Executive Regulatory Affairs role ranges between ₹8 LPA – ₹14 LPA, depending on experience and expertise.

Employee Benefits at Ferring

Ferring Pharmaceuticals offers comprehensive employee benefits including:

  • 26 weeks paid parental leave
  • Fertility treatment support
  • Adoption and surrogacy assistance
  • Egg freezing support
  • Counseling services
  • Paid leave for fertility and adoption procedures

Why This Regulatory Affairs Job is Important

This Hyderabad-based Regulatory Affairs position is ideal for professionals seeking growth in:

  • CDSCO regulatory submissions
  • Pharmaceutical dossier preparation
  • India and global regulatory compliance
  • Pharmacovigilance operations
  • Clinical trial documentation

The role also provides exposure to cross-functional pharmaceutical operations and international regulatory practices.

How to Apply

Application Link

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