ProductLife Group (PLG) is actively hiring experienced professionals for Regulatory Affairs and Pharmacovigilance roles in India with remote work flexibility. This is an excellent opportunity for candidates with 3–7 years of experience in Regulatory Affairs, eCTD publishing, UK/EU submissions, or Drug Safety (PV) to work in a global consulting environment.

These roles offer exposure to international regulatory agencies such as TGA, Medsafe, MHRA, and EMA, making them highly valuable for career growth in global life sciences.

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🔍 Open Positions

1. RA Officer (Associate Consultant) – JAPAC (Australia & New Zealand)

Key Responsibilities:

• Support registration and lifecycle management of pharmaceuticals, biologics, and medical devices
• Prepare and submit regulatory dossiers (CTD/eCTD)
• Handle submissions to TGA and Medsafe
• Assist in GMP clearance applications
• Respond to regulatory authority queries
• Support client and project management activities

Required Qualifications:

• Bachelor’s in Pharmaceutical Sciences or related field
• Minimum 3+ years in Regulatory Affairs
• Knowledge of TGA & Medsafe regulations
• Strong communication and documentation skills

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2. Regulatory Affairs Specialist – UK & EU Legislation

Key Responsibilities:

• Manage Marketing Authorisation Applications (MAA) (UK/EU)
• Handle Variations, Renewals, Line Extensions, MAH Transfers
• Prepare CTD/eCTD dossiers and lifecycle submissions
• Ensure compliance with MHRA & EMA regulations
• Coordinate with cross-functional teams (PV, QA, Supply Chain)
• Support regulatory inspections and audits

Required Qualifications:

• Bachelor’s/Master’s in Life Sciences or Pharmacy
• 3–7 years of Regulatory Affairs experience
• Strong knowledge of UK/EU regulatory frameworks
• Experience with Veeva Vault, LorenZ, Trackwise preferred

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3. Case Specialist – Pharmacovigilance (Drug Safety)

Key Responsibilities:

• Perform ICSR case processing and quality control
• Conduct medical evaluation and causality assessment
• Coding using standard dictionaries (MedDRA, WHO-Drug)
• Handle follow-ups, case closure, and submissions
• Identify safety signals and regulatory reporting requirements
• Support medical information and safety reporting systems

Required Qualifications:

• PharmD / B.Pharm / M.Pharm (Pharmacist preferred)
• 4–5 years of Pharmacovigilance experience
• Strong knowledge of global safety regulations
• Experience in database systems and case processing tools

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💼 Salary & Benefits

• Estimated Salary Range: ₹6 LPA – ₹14 LPA (based on role & experience)
• 100% Remote Work Opportunity
• Exposure to global regulatory markets (Australia, EU, UK)
• Opportunity to work in consulting-based life sciences projects
• Career growth in Regulatory Affairs & Drug Safety domains

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📌 Why Join ProductLife Group?

• Global presence in Regulatory Affairs, PV, and Quality Consulting
• Work with international clients and regulatory agencies
• Strong learning and development environment
• Ideal for professionals aiming for global RA/PV careers

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📩 How to Apply

Application Link For RA Officer (Associate Consultant) Australia and New Zealand and (JAPAC) region

Application Link For Regulatory Affairs Specialist – UK Legislation

Application Link For Case Specialist (India)