Expert – Regulatory CMC
📍 Location: Bangalore, Karnataka, India
🆔 Job ID: 291455
💼 Job Type: Full-time
About Us
We believe in working your magic. Our colleagues across the globe innovate with science and technology to enrich lives in Healthcare, Life Science, and Electronics.
Vision: Explore, break barriers, and discover the unimaginable.
Commitment: Caring for people, customers, patients, and the planet.
Culture: Diverse, inclusive, and collaborative – empowering you to grow at your own pace while making a global impact.
Your Role
As an Expert in Regulatory CMC, you will support and implement CMC Regulatory Intelligence activities in a non–product-specific role. Key responsibilities include:
Maintain and continuously improve databases (e.g., CMC Regulatory Country Requirements, LCM/Investigational Medicinal Product Catalogues, Wiki-handbook).
Collaborate with external data providers for database accuracy.
Actively participate in Change Control Process meetings.
Chair Quality Regulatory Assessment Committee (QRAC) meetings and monthly update sessions.
Author/co-author position papers and responses to Regulatory CMC queries.
Serve as SME for guideline revisions.
Ensure alignment between CMC Regulatory Intelligence and GRA CMC & Device teams (improving interoperability, agility, and engagement).
Contribute to activities for small molecules, large molecules, and medical devices (drug-device combinations) in marketed post-approval settings.
Participate in Trade Association calls (observer/listener) and incorporate insights into CMC Regulatory Intelligence databases.
Provide support for digitalization projects.
Ensure effective utilization of the Veeva system for all CMC regulatory activities.
Who You Are
Education
Degree in Life Science, Medical, PharmD, or related discipline (minimum MSc or equivalent).
Higher degree (PhD in a scientific discipline) or education in Regulatory Affairs preferred.
Experience
10+ years overall work experience in pharma environment, competent authority, academia, R&D, or consultancy relevant to CMC Regulatory Intelligence.
Minimum 5 years of Global CMC regulatory experience.
What We Offer
A culture celebrating diversity of backgrounds, perspectives, and experiences.
Opportunities for personal and professional growth at your own pace.
Commitment to innovation, inclusion, and belonging.
A global platform to work your magic and champion human progress.
Important Notice
⚠️ Beware of fraudulent job offers. We do not authorize third parties to represent our company with employment opportunities. Please refer to our official fraud prevention notice for more details.
Application Process
If you applied before April 16, 2025, log into your old profile to check application status.
For new applications (including this one), create a new applicant profile to track status.
✅ Apply now and join our team to make an impact through science and innovation!
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Auckland |New Zealand :
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Manila |Croatia :
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