IQVIA is currently hiring a Regulatory Affairs Specialist (CMC Module 3 & Veeva Vault) for a 100% Work From Home (WFH) position.
This remote Regulatory Affairs job is ideal for professionals with 2–3 years of experience in CMC Module 3 authoring, global regulatory submissions, and Veeva Vault document management. Candidates will collaborate with international regulatory, manufacturing, quality assurance, and R&D teams while supporting worldwide pharmaceutical submissions.
If you’re looking for a remote Regulatory Affairs job in 2026, this opportunity offers excellent career growth, international exposure, and the flexibility of working from home.
Job Overview
| Details | Information |
|---|---|
| Company | IQVIA |
| Job Title | Regulatory Affairs Specialist |
| Department | Regulatory Affairs |
| Work Mode | 100% Remote / Work From Home |
| Experience | 2–3 Years |
| Qualification | B.Pharm, M.Pharm, M.Sc., or relevant Life Sciences degree |
| Specialization | CMC Module 3 Authoring |
| Software | Veeva Vault |
| Industry | Pharmaceutical / Biotechnology |
| Application Mode |
About the Role
IQVIA is seeking an experienced Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management activities. The selected professional will prepare and review CMC Module 3 documentation, manage regulatory documents in Veeva Vault, respond to Health Authority queries, and ensure compliance with international regulatory guidelines.
This remote opportunity enables professionals to work with global pharmaceutical teams while building expertise in worldwide regulatory submissions.
Key Responsibilities
The selected candidate will be responsible for:
- Prepare and author CMC Module 3 documentation
- Review manufacturing, analytical, and quality-related data
- Compile dossiers for global regulatory submissions
- Support lifecycle management activities
- Prepare responses to Health Authority questions
- Coordinate with QA, Manufacturing, R&D, and Regulatory Affairs teams
- Manage documentation using Veeva Vault
- Maintain submission timelines and regulatory trackers
- Ensure compliance with ICH and international regulatory guidelines
- Support marketing authorization applications, renewals, and product variations
CMC Module 3 Responsibilities
Professionals working in CMC Module 3 Authoring prepare documentation related to pharmaceutical manufacturing and product quality.
Drug Substance (3.2.S)
Responsibilities include:
- API manufacturing process documentation
- Characterization reports
- Analytical procedures
- Specifications
- Stability data
- Quality control documentation
Drug Product (3.2.P)
Documentation includes:
- Product formulation
- Manufacturing process
- Process validation
- Packaging information
- Container closure systems
- Stability studies
- Finished product specifications
Candidates should possess strong scientific writing skills to transform technical manufacturing information into regulatory-compliant documentation.
Health Authority Query Management
Following regulatory submissions, Health Authorities frequently request additional technical information.
The Regulatory Affairs Specialist will:
- Review Health Authority queries
- Identify supporting scientific documentation
- Coordinate with Manufacturing and QA teams
- Draft scientifically accurate responses
- Meet regulatory submission timelines
Excellent scientific writing and communication skills are essential for this responsibility.
Veeva Vault Experience
Hands-on knowledge of Veeva Vault is mandatory.
Key responsibilities include:
- Regulatory document management
- Workflow approvals
- Version control
- Metadata management
- Submission tracking
- Electronic document organization
- Document lifecycle management
Experience with Veeva Vault Regulatory Information Management (RIM) will be an added advantage.
Required Qualifications
Candidates should possess:
- B.Pharm, M.Pharm, M.Sc., or relevant Life Sciences qualification
- 2–3 years of Regulatory Affairs experience
- Expertise in CMC Module 3 Authoring
- Strong scientific writing skills
- Knowledge of ICH guidelines
- Experience with global regulatory submissions
- Hands-on experience with Veeva Vault
- Excellent documentation practices
- Strong written and verbal communication skills
- Ability to work independently in a remote environment
Desired Skills
Successful candidates should demonstrate:
- Strong attention to detail
- Time management skills
- Cross-functional collaboration
- Problem-solving ability
- Accountability
- Self-motivation
- Adaptability to changing regulatory requirements
- Ability to collaborate with global teams across multiple time zones
Why Join IQVIA?
This remote Regulatory Affairs opportunity offers several career advantages:
- 100% Work From Home
- International regulatory exposure
- Flexible remote work environment
- Opportunity to support global submissions
- Hands-on experience with Veeva Vault
- Career growth in Regulatory Affairs
- Cross-functional collaboration with global pharmaceutical teams
- Stable long-term pharmaceutical industry opportunity
Salary (Estimated)
Based on current market trends and similar Regulatory Affairs roles:
Estimated Salary: ₹8,00,000 – ₹12,00,000 per annum (CTC)
Actual compensation may vary depending on candidate experience, skills, interview performance, and company policies.
How to Apply
Interested candidates should update their resume highlighting:
- CMC Module 3 experience
- Veeva Vault expertise
- Global Regulatory Submission experience
- Regulatory Affairs achievements
Suggested Email Subject
Application: Regulatory Affairs Specialist – Your Name – Years of Experience