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Regulatory Specialist

2-3 years
₹4 – ₹6.5 LPA
10 June 14, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Specialist – 2 to 3 Years' Experience
Location: Hyderabad | Employment Type: Full-time
Company: Navatio Pharma Solutions Private Limited

Job Description:
Navatio Pharma is seeking a Regulatory Specialist with 2–3 years of experience in regulatory affairs to join our dynamic and compliance-driven team. If you have a strong background in pharmaceutical regulatory submissions and a passion for quality and precision, this is your opportunity to grow with a forward-thinking organization.

Key Responsibilities:

  • Prepare, compile, and review regulatory submissions such as CTD dossiers, DMFs, ANDAs.

  • Maintain regulatory approvals and registrations for pharmaceutical products.

  • Ensure timely submissions to national and international authorities including CDSCO, USFDA, EMA, and others.

  • Track and implement updates in global regulatory requirements.

  • Handle post-approval changes, documentation, variations, and renewals.

  • Support regulatory audits and inspections by providing necessary documentation.

  • Maintain internal regulatory tracking systems and ensure the accuracy of documentation.

Qualifications:

  • Bachelor’s or Master’s degree in Pharmacy or Life Sciences.

  • 2 to 3 years of hands-on experience in regulatory affairs, preferably in the pharmaceutical sector.

  • Excellent documentation, organizational, and communication skills.

How to Apply:
Interested candidates should send their resume to
hr@navatiopharma.com

Estimated Salary Range: ₹4 – ₹6.5 LPA (based on experience and qualifications)