Job Title:
Expert Regulatory CMC
📍 Location: Bangalore, Karnataka, India
🕒 Job Type: Full-time
🔢 Job ID: 291455
Company Overview
At our company, we’re driven by science and technology to enrich lives through innovations in Healthcare, Life Science, and Electronics. Our purpose is to challenge limits, empower diversity, and imagine the unimaginable—always prioritizing people, patients, and the planet.
We’re looking for curious minds who are ready to work their magic and bring value across the globe.
Position Overview
As an Expert Regulatory CMC, you will support and implement CMC Regulatory Intelligence activities across small molecules, large molecules, and combination medical devices.
This is a non-product-specific role focusing on strategy, data integrity, regulatory guidance, and digital systems to enable compliant post-approval regulatory operations.
Key Responsibilities
📊 CMC Regulatory Intelligence Operations
Maintain and continuously improve regulatory databases:
CMC Regulatory Country Requirements
Life Cycle Management & Investigational Medicinal Product Catalogues
Wiki-handbook
Liaise with external data providers for database updates
🧩 Strategic Regulatory Engagement
Active participant in:
Change Control Process meetings
Quality Regulatory Assessment Committee (QRAC) (Chair)
Monthly update sessions
Co-author/author:
Position papers
Responses to CMC regulatory queries
Subject matter input on guideline revisions
🧠 Cross-functional Collaboration
Ensure alignment between:
CMC Regulatory Intelligence
GRA CMC & Device teams
Enhance interoperability, agility, and cohesion across departments
💊 Domain Expertise
Contribute to regulatory strategies for:
Small molecules
Biologics
Drug-device combination products (medical devices)
🏛️ Trade Association Representation
Join industry calls in a learning/observer role
Leverage learnings into internal database insights
🔧 Digital & Data Systems
Support digitalization projects and process automation
Efficiently utilize Veeva Vault system for regulatory CMC documentation
Candidate Profile
🎓 Education
Minimum: Master’s degree (MSc) in:
Life Sciences
Pharmacy
Medical Sciences
Related field
Preferred: PhD or formal education in Regulatory Affairs
💼 Experience
10+ years total industry experience (pharma, regulatory agency, academia, consultancy)
Minimum 5 years of Global Regulatory CMC experience
Desired Skills & Competencies
Deep understanding of CMC regulatory requirements across global markets
Strong analytical, communication, and documentation skills
Proactive approach to compliance, digital transformation, and innovation
Ability to influence cross-functional teams and drive regulatory alignment
What We Offer
💰 Financial & Savings
401(k) plan with:
Company match
Annual discretionary contributions
Tax-advantaged accounts for:
Healthcare
Commuting
Insurance buy-ups (life, accident, etc.)
❤️ Health & Wellness
Medical, dental, and vision coverage
Telehealth access
Free counseling sessions via EAP
Personalized wellness programs
🏡 Work-Life Support
Generous Paid Time Off (PTO)
Back-up daycare support
Educational assistance programs
Work/life balance tools
🛍️ Voluntary Benefits
Discounts on:
Auto, home, and pet insurance
Low-interest personal loans
Supplemental healthcare coverage
Recruitment Process
Apply Online
Submit your application via the career portal
Or join our Talent Zone to stay informed
Screening
Applications reviewed for best-fit criteria
Assessment
Interviews conducted via phone, video, or onsite
Offer
Mutual agreement and onboarding
Onboarding
Support to ensure a smooth and successful start
Equal Opportunity Employer
We are committed to diversity, equity, and inclusion. No discrimination is made on the basis of race, gender, disability, veteran status, or any other protected status. Retaliation for good faith reporting of discrimination is not tolerated.
Beware of Fraudulent Job Offers
⚠️ We are aware of fraudulent job offers claiming to represent our company. Please verify all offers through our official career website. More Info
How to Apply
👉 Apply Now via our Official Careers Portal
🔎 Not ready yet? Join our Talent Zone and stay connected.
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