Regulatory Affairs Officer 2
Company: IQVIA
Job Title: Regulatory Affairs Officer 2
Job ID: R1557288
Job Type: Full-time
Location: Bengaluru, Karnataka, India
Work Model: Home-based
Experience Required
3–4 years of relevant experience in Regulatory Affairs, Regulatory Operations, Clinical Research, or Life Sciences.
Experience handling regulatory documentation, submissions, and compliance activities is preferred.
Educational Qualification
Candidates should possess:
Bachelor's Degree in Life Sciences or related discipline
OR
Master's Degree in Life Sciences or related discipline
Department
Regulatory Affairs – Life Sciences / Clinical Research
Job Summary
IQVIA is hiring a Regulatory Affairs Officer 2 who will work as an individual contributor with advanced regulatory knowledge and minimal supervision. The role involves preparing and reviewing regulatory documents, supporting regulatory submissions, managing client interactions, providing regulatory expertise, and ensuring compliance with global regulatory requirements.
The selected candidate will support areas such as Chemistry, Manufacturing & Controls (CMC), Lifecycle Maintenance, Marketing Authorization Transfers, Labeling, and Regulatory Publishing.
Key Responsibilities
Act as a Regulatory Team Leader for complex regulatory projects.
Prepare and review regulatory documentation based on project requirements.
Support technical writing activities for regulatory submissions.
Establish and maintain relationships with clients and stakeholders.
Discuss regulatory issues, provide updates, and address customer feedback.
Provide Subject Matter Expert (SME) support in regulatory areas including:
Chemistry, Manufacturing & Controls (CMC)
Lifecycle Maintenance
Marketing Authorization Transfers
Labeling
Regulatory Publishing
Understand project scope, deliverables, timelines, and budgets.
Manage workload across multiple regulatory projects.
Guide junior team members and provide document quality feedback.
Participate in client meetings and regulatory discussions.
Review regulatory Standard Operating Procedures (SOPs).
Prepare and deliver regulatory training sessions.
Support process improvements within regulatory operations.
Required Skills
Regulatory Affairs
Regulatory Documentation
Regulatory Submissions
Technical Writing
Chemistry, Manufacturing & Controls (CMC)
Clinical Development Process
Preclinical and Clinical Research Knowledge
Regulatory Guidelines and Compliance
Lifecycle Management
Labeling Activities
Regulatory Publishing
SOP Review
Project Management
Client Communication
Microsoft Office Applications
Regulatory Publishing Tools
Documentation Review
Quality Management
Preferred Qualifications
Strong understanding of drug development lifecycle:
Preclinical research
Clinical trials
Manufacturing processes
Regulatory submissions
Ability to independently manage regulatory tasks.
Experience working with global regulatory requirements.
Strong written and verbal communication skills.
Ability to handle multiple projects simultaneously.
Adaptability to changing regulatory environments.
Roles and Responsibilities
Work independently under limited supervision.
Apply regulatory expertise to assigned projects.
Solve regulatory issues and recommend process improvements.
Maintain compliance with regulatory standards and SOPs.
Make decisions on assigned tasks while collaborating with senior regulatory professionals.
Support team development through knowledge sharing and training.
Work Environment
Full-time employment.
Home-based work model.
Collaboration with global regulatory teams.
Client interaction and project-based responsibilities.
About IQVIA
IQVIA is a global provider of clinical research services, healthcare intelligence, and commercial insights for the life sciences industry. The company supports pharmaceutical, biotechnology, and healthcare organizations in developing and commercializing innovative medical treatments through advanced technology, analytics, and research solutions.
Estimated Salary Package
The official job posting does not disclose the salary. Based on current market trends for Regulatory Affairs Officer roles in Bengaluru:
|
Experience |
Estimated Annual CTC |
|---|---|
|
3–4 years |
₹7 – ₹10 LPA |
|
4–6 years |
₹9 – ₹14 LPA |
Expected Average CTC: ₹8–12 LPA, depending on regulatory expertise, technical writing skills, project experience, and IQVIA's compensation policies.
Who Should Apply
Candidates with:
Bachelor's or Master's degree in Life Sciences or related fields.
3–4 years of experience in Regulatory Affairs.
Knowledge of regulatory documentation and submission processes.
Understanding of drug development and regulatory guidelines.
Experience with CMC, labeling, lifecycle management, or publishing activities.
Strong communication, organizational, and problem-solving skills.
Location
Bengaluru, Karnataka, India
Employment Type
Full-time
Home-based
Key Highlights
Opportunity to work with global pharmaceutical and biotechnology clients.
Exposure to international regulatory processes.
Experience in CMC, labeling, regulatory submissions, and lifecycle management.
Opportunity to act as a regulatory subject matter expert.
Remote work flexibility through a home-based model.
Career growth opportunities in Regulatory Affairs and Clinical Research.
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