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Ra Officer (Associate Consultant) – Regulatory Affairs

Plg Groups
PLG groups
3+ years
preferred by company
Remote
1 May 13, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien, Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified

Job Title: RA Officer (Associate Consultant) – Regulatory Affairs

Location: India (Remote)
Employment Type: Permanent / Full-Time
Department: Regulatory Affairs & Operations / Product Lifecycle Management
Industry: Pharmaceuticals / Biologics / Medical Devices / Life Sciences

Job Overview

We are looking for a skilled Regulatory Affairs (RA) Officer – Associate Consultant to support global regulatory operations for pharmaceuticals, biologics, and medical devices across the Australia, New Zealand, and JAPAC regions. This role involves regulatory submissions, lifecycle management, eCTD publishing, GMP clearance applications, and direct support for regulatory authority interactions.

This opportunity is ideal for professionals with strong experience in regulatory affairs, dossier preparation, health authority submissions, lifecycle maintenance, and pharmaceutical compliance.


Key Responsibilities

Regulatory Registration & Product Listings

  • Support product registration and listing activities for:
    • Pharmaceuticals
    • Biological products
    • Medical devices
  • Manage regulatory support for:
    • Australia
    • New Zealand
    • JAPAC markets
  • Assist clients with product approval and market access documentation.

Lifecycle Management

  • Support maintenance of approved product registrations and listings.
  • Handle post-approval regulatory activities including:
    • Variations
    • Renewals
    • Amendments
    • Product updates
    • Ongoing compliance maintenance

eCTD Publishing

  • Provide end-to-end eCTD publishing support.
  • Prepare, validate, organize, and manage electronic regulatory submissions.
  • Ensure submission documents meet authority formatting and compliance standards.

Regulatory Dossier Preparation

  • Review, critically evaluate, prepare, and submit regulatory dossiers.
  • Compile submission documentation for regulatory approvals and maintenance activities.
  • Ensure completeness, scientific accuracy, and compliance.

Health authority exposure:

  • TGA (Therapeutic Goods Administration – Australia)
  • Medsafe (New Zealand regulatory authority)

Regulatory Query Management

  • Support responses to health authority questions and deficiency letters.
  • Assist clients in preparing timely and compliant responses to:
    • TGA queries
    • Medsafe queries
    • Other regulatory agency communications

Complex Regulatory Applications

  • Assist senior regulatory consultants with preparation of complex regulatory applications.
  • Support submission planning and documentation for advanced regulatory projects.
  • Contribute to strategic regulatory execution.

GMP Clearance Applications

  • Prepare and manage GMP clearance submissions.
  • Support manufacturing compliance documentation.
  • Coordinate regulatory requirements for GMP approvals.

Quality Documentation

  • Prepare, review, and update:
    • Regulatory quality documentation
    • Compliance documentation
    • Controlled documents
    • Internal quality records

Project & Client Management Support

  • Support:
    • Regulatory project coordination
    • Submission tracking
    • Client communication
    • Timeline management
    • Deliverables monitoring
  • Collaborate with internal teams and clients for smooth project execution.

Required Qualifications

Education
Bachelor’s degree / Undergraduate qualification in:

  • Pharmaceutical Sciences
  • Pharmacy
  • Life Sciences
  • Biotechnology
  • Chemistry
  • Related scientific disciplines