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Regulatory Specialist

Navatio Pharma Private Limited
Navatio Pharma Private Limited
2-4 years
₹4 – ₹8 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

Job Title: Regulatory Specialist
Location: Not Specified (Please confirm in application)
Job Type: Full-Time

Job Summary:
Navatio Pharma is currently hiring for the position of Regulatory Specialist. We are looking for a motivated and detail-oriented professional to join our regulatory affairs team and support the preparation, submission, and maintenance of regulatory documentation in compliance with applicable guidelines.

Key Responsibilities:

  • Prepare, review, and submit regulatory dossiers to health authorities

  • Maintain up-to-date knowledge of global regulatory requirements (FDA, EMA, ICH, etc.)

  • Ensure all product-related documentation complies with applicable regulations

  • Liaise with internal departments for timely collection of technical and quality documents

  • Respond to queries from regulatory agencies in a timely and accurate manner

  • Track and manage regulatory submissions and product registrations

Qualifications:

  • Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field

  • 2–4 years of experience in regulatory affairs (pharma/biotech sector preferred)

  • Strong knowledge of global regulatory frameworks and submission formats

  • Excellent attention to detail and organizational skills

  • Good communication skills, both written and verbal

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

Estimated Salary Range: ₹4 – ₹8 LPA (based on experience and skill level)