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Ra Officer (Associate Consultant) – Regulatory Affairs

Productlife Group
ProductLife Group
3+ years
preferred by company
Remote, India, India
1 May 12, 2026
Job Description
Job Type: Remote Education: M.Pharm/B.Pharm or M.Sc. Skills: CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing

RA Officer (Associate Consultant) – Regulatory Affairs

Job Category: Regulatory Affairs / Pharmaceutical Compliance / Healthcare Consulting
Department: Regulatory Affairs & Operations
Location: India
Work Mode: Remote / Work From Home Available
Employment Type: Permanent / Full-Time
Experience Required: Minimum 3+ Years (Freshers Not Eligible)

About the Role

A growing healthcare and life sciences consulting organization is seeking an experienced RA Officer (Associate Consultant) to join its Regulatory Affairs & Operations team. This role is ideal for professionals with expertise in pharmaceutical regulatory affairs, medical device registration, biologics compliance, regulatory dossier preparation, eCTD publishing, and global market authorization support.

The selected candidate will provide regulatory support for pharmaceutical, biologic, and medical device product registrations across Australia, New Zealand, and the JAPAC region, while supporting regulatory submissions, maintenance activities, compliance documentation, and client advisory services.

This is an excellent opportunity for professionals looking to advance their career in global regulatory affairs, pharmaceutical compliance, regulatory consulting, medical device registration, and market authorization strategy.

Key Responsibilities

  • Support clients with pharmaceutical, biologics, and medical device registrations across Australia, New Zealand, and the JAPAC region.
  • Assist with product registration, listing, lifecycle maintenance, and regulatory compliance management.
  • Prepare, review, and submit regulatory dossiers to agencies including:
    • Therapeutic Goods Administration (TGA)
    • Medsafe
    • Other relevant international regulatory authorities
  • Provide eCTD publishing support for regulatory submissions.
  • Critically review regulatory documentation to ensure compliance with submission standards and market requirements.
  • Assist clients in preparing responses to regulatory authority queries, deficiencies, and information requests.
  • Support senior regulatory consultants in the preparation of complex regulatory submissions and strategic applications.
  • Prepare and manage GMP clearance applications for regulatory agency submissions.
  • Assist with regulatory project coordination, client communication, and submission timelines.
  • Prepare, review, and maintain quality management and regulatory compliance documentation.
  • Ensure confidentiality and compliance while handling sensitive regulatory and client information.

Required Qualifications

  • Bachelor’s degree in:
    • Pharmaceutical Sciences
    • Life Sciences
    • Biotechnology
    • Chemistry
    • Other related scientific disciplines
  • Minimum 3 years of regulatory affairs experience
  • Prior experience in commercial regulatory affairs environments
  • Strong understanding of pharmaceutical and medical device regulatory workflows

Required Technical Skills

  • Strong knowledge of:
    • TGA regulations, legislation, and submission requirements
    • Medsafe regulatory frameworks
    • Pharmaceutical regulatory compliance processes
    • Medical device registration pathways
    • Biologics regulatory documentation
    • GMP clearance procedures
    • eCTD publishing workflows
  • Reasonable computer literacy and document management capabilities
  • Strong regulatory documentation review and dossier preparation expertise