If you’re an experienced pharma professional with expertise in Regulatory Affairs and Chemistry, Manufacturing, and Controls (CMC)—then this career-defining opportunity at IQVIA is tailor-made for you. Based in Bangalore, this Regulatory Affairs Manager – CMC role offers a premium salary package of ₹18–35 LPA, and a front-row seat in the fast-paced world of global drug approvals.
IQVIA, a global leader in healthcare analytics, research, and compliance, is seeking individuals with 8–12 years of experience to lead regulatory strategies, submissions, and compliance operations that impact drug launches worldwide.
📍 Job Location
Bangalore, India
(Hybrid flexibility likely, based on team structure and deliverables)
🎓 Eligibility Criteria
- Education: Bachelor’s or Master’s in Pharmacy (B.Pharm/M.Pharm), Biotechnology, Life Sciences, or related disciplines
- Experience: 8 to 12 years in CMC Regulatory Affairs, preferably with exposure to global submissions (US, EU, ROW)
💼 Salary
₹18–35 LPA (Based on experience and domain expertise)
🧾 Key Responsibilities
As a Regulatory Affairs Manager (CMC), you’ll play a mission-critical role in ensuring products meet global compliance standards and secure timely approvals from health authorities. Here’s what your role will look like:
🔹 Develop & Drive Global Regulatory CMC Strategy
- Design robust, forward-looking CMC regulatory strategies to fast-track clinical trials and marketing applications.
- Plan global variations, lifecycle management, and submission plans.
🔹 Submission Preparation & Compilation
- Compile CMC sections of dossiers for eCTD, CTAs, variations, and supplements across multiple regions.
- Ensure documentation aligns with global eCTD module requirements, particularly Module 3 (Quality).
🔹 Lead Cross-Functional Teams
- Manage a team of Subject Matter Experts (SMEs) in CMC and ensure interdepartmental collaboration with Manufacturing, QA, and Quality Control.
- Represent the Regulatory CMC function in project meetings.
🔹 Gap Assessment & Risk Mitigation
- Review technical data for regulatory gaps, inconsistencies, or risk areas.
- Suggest and implement remediation strategies based on guidelines.
🔹 Health Authority Interactions
- Handle FDA, EMA, and global agency queries related to CMC dossiers.
- Coordinate responses, documentation updates, and justifications to secure approvals.
🔹 Strategic Planning
- Prepare CMC submission timelines and ensure strict adherence.
- Conduct impact assessments of any changes in manufacturing sites, processes, or suppliers.
🔹 Ensure Compliance with International Guidelines
- Maintain knowledge and provide guidance on ICH Q series, FDA, and EMA CMC regulatory expectations.
- Ensure compliance with Veeva Vault and internal document management systems.
🧠 Core Skills Required
✅ Technical Knowledge
- In-depth understanding of ICH, USFDA, EU, and ROW CMC guidelines
- Strong knowledge of drug manufacturing processes, stability, specifications, and validation
✅ Documentation & Compliance
- Hands-on experience with eCTD submissions, document formatting, and module compilation
- Familiarity with Veeva Vault, MasterControl, or other regulatory software tools
✅ Communication & Leadership
- Excellent cross-functional communication and team-leading ability
- Strategic mindset to balance compliance with business needs
🏢 About IQVIA
IQVIA is a global powerhouse in clinical research, real-world evidence, and pharmaceutical strategy consulting. With a presence in over 100 countries, IQVIA helps life sciences companies bring treatments to market faster and smarter.
IQVIA combines cutting-edge tech with deep domain expertise to deliver AI-powered analytics, site optimization, and regulatory compliance support. Working here means contributing to a healthier, more data-driven future in healthcare.
🎯 Why This Role Matters
In the highly regulated pharmaceutical world, the CMC Manager acts as the gatekeeper of compliance, ensuring that all scientific and manufacturing data stand up to scrutiny from global agencies.
This role is perfect for someone who enjoys problem-solving, scientific interpretation, regulatory dialogue, and leading global submissions. If you’re ready for a high-impact position with global visibility, this is it.
🗓 Application Deadline
Apply before: May 12, 2025
🚀 Career Growth Opportunities
After joining IQVIA as a Regulatory Affairs Manager (CMC), your career path could evolve into:
- ➡️ Associate Director – Global Regulatory Affairs
- ➡️ CMC Strategy Lead for Global Product Portfolios
- ➡️ Regulatory Compliance & Intelligence Head
- ➡️ Cross-Functional Regulatory Affairs Director
💡 Final Thoughts
If you’ve built a strong foundation in Regulatory Affairs – CMC and are ready to take it global, IQVIA is offering you the perfect springboard. With challenging projects, attractive pay, global exposure, and a team of experts, this is not just a job—it’s a career milestone.
Seize this opportunity to shape the future of pharma compliance, one regulatory submission at a time.
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