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Regulatory Affairs Officer

2+ years
Not Disclosed
10 July 24, 2025
Job Description
Job Type: Hybrid 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 Affairs Officer – Hybrid (Bengaluru)

Job Summary:
IQVIA is seeking a Regulatory Affairs Officer with 2+ years of experience to support regulatory submissions, marketing authorization activities, and clinical trial documentation. This hybrid role offers the opportunity to work on cutting-edge pharmaceutical and life sciences projects while collaborating with global clients and regulatory experts.


Key Responsibilities:

  • Prepare and review regulatory submissions for clinical trials and marketing authorization activities.

  • Act as a Regulatory Team Member on small regulatory projects under senior guidance.

  • Track project timelines, manage deliverables, and implement client requests.

  • Collaborate with internal and external teams to ensure high-quality regulatory outputs.

  • Draft slides, background material, and contribute to business development meetings.

  • Support training sessions and assist with process improvements.

  • Make minor changes in systems and processes to resolve regulatory issues.


Required Skills & Qualifications:

  • Bachelor’s or Master’s degree in Life Sciences or a related discipline.

  • Minimum 2 years of relevant experience in regulatory affairs.

  • Strong understanding of Chemistry, Manufacturing & Controls (CMC) and marketing authorization processes.

  • Proficiency in Microsoft Office and regulatory publishing tools.

  • Excellent written and verbal communication skills.

  • Ability to manage multiple projects with attention to detail.

  • Self-motivated, with a proactive approach to process improvement.


Perks & Benefits:

  • Hybrid work model for work-life flexibility.

  • Exposure to global regulatory processes and clients.

  • Continuous learning and career growth opportunities.

  • Collaborative work environment with industry experts.


Company Description:

IQVIA is a global leader in clinical research services, healthcare analytics, and life sciences consulting. By combining advanced technology with deep healthcare expertise, IQVIA accelerates drug development and improves patient outcomes worldwide.


Work Mode: Hybrid – Bengaluru, India.


Call-to-Action:
Advance your regulatory affairs career with IQVIA. Apply now for the Regulatory Affairs Officer role in Bengaluru and work with a global leader in healthcare solutions.