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Regulatory Operations Associate

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ICON
1-3 years
Not Disclosed
Bangalore, India
10 March 11, 2026
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 Operations Associate – ICON plc (Bangalore)

ICON plc is hiring a Regulatory Operations Associate in Bangalore, India for professionals interested in clinical research, regulatory affairs, and pharmaceutical regulatory submissions. In this role, you will support global regulatory teams by managing regulatory document publishing, submission preparation, and regulatory compliance activities for pharmaceutical and biotechnology clients. You will work closely with cross-functional clinical development teams, regulatory specialists, and project managers to ensure accurate and timely regulatory submissions that comply with international regulatory guidelines. This role is ideal for candidates with experience in regulatory operations, clinical research documentation, and pharmaceutical regulatory processes. The estimated salary for this role ranges from ₹5 LPA to ₹8 LPA depending on experience in regulatory operations and clinical research support.

Key Responsibilities

  • Execute publishing, compilation, and submission of global regulatory documents for pharmaceutical and biotechnology projects.

  • Ensure timely and accurate regulatory submissions according to international regulatory guidelines.

  • Maintain and organize regulatory documentation and submission records.

  • Collaborate with clinical research teams, regulatory specialists, and project stakeholders.

  • Support regulatory compliance activities and document management processes.

  • Maintain updated knowledge of global regulatory requirements and submission standards.

  • Contribute to process improvement initiatives within regulatory operations.

Required Qualifications

  • Bachelor’s degree in a scientific, life sciences, or healthcare-related field.

  • 1–3 years of experience in regulatory operations within the pharmaceutical or biotechnology industry.

  • Familiarity with regulatory submission tools and document management systems.

  • Strong attention to detail and excellent organizational skills.

  • Ability to work collaboratively in cross-functional clinical research teams.

Required Skills

  • Regulatory Operations

  • Regulatory Submissions & Publishing

  • Clinical Research Documentation

  • Pharmaceutical Regulatory Compliance

  • Document Management Systems

  • Cross-Functional Collaboration

  • Attention to Detail & Process Management

Salary

Approximate Salary: ₹5,00,000 – ₹8,00,000 per year (depending on experience in regulatory operations and clinical research).