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Looking for Regulatory Affairs Specialist jobs in Hyderabad? A leading global life sciences company, Lonza, is hiring skilled professionals for its Global Capability Center (GCC) in Hyderabad. This is an excellent opportunity for candidates with experience in CMC regulatory writing, eCTD submissions, and Veeva Vault to advance their careers in regulatory affairs.
If you have a background in life sciences, chemistry, or biology, and are aiming for a high-growth regulatory career, this Regulatory Affairs Specialist (CMC) role offers global exposure and career progression.
Job Overview
- Role: Regulatory Affairs Specialist (CMC)
- Location: Hyderabad, India
- Company: Lonza
- Reference ID: R75283
- Job Type: Full-time
- Department: Regulatory Affairs / CMC
Key Responsibilities
- Support regulatory dossier preparation for clinical trial applications
- Perform CMC regulatory writing using source documentation
- Ensure submissions are accurate, complete, and compliant with global regulations
- Manage product lifecycle activities and regulatory updates
- Handle Veeva Vault workflows, trackers, and document systems
- Collaborate with global regulatory teams for successful submission outcomes
- Coordinate eCTD publishing and regulatory submissions
Required Qualifications
- Bachelorโs or Masterโs degree in Chemistry, Biology, or Life Sciences
- Strong understanding of global regulatory requirements and CMC documentation
- Hands-on experience with:
- Veeva Vault
- eCTD publishing
- Regulatory document management systems
- Excellent project management and multitasking skills
- Strong communication skills with business-level English proficiency
- Proactive, collaborative, and solution-oriented mindset
Preferred Skills (High SEO Value Keywords)
- Regulatory Affairs Specialist CMC
- Clinical trial application submissions
- Global regulatory submissions
- eCTD lifecycle management
- Veeva Vault regulatory jobs
- Pharma regulatory writing jobs Hyderabad
Salary & Benefits
- Estimated Salary: โน6,00,000 โ โน10,00,000 per annum
- Performance-based compensation programs
- Global exposure with cross-functional teams
- Continuous learning & development opportunities
- Inclusive and ethical workplace culture
Why Join Lonza?
Lonza is a globally recognized leader in pharmaceutical manufacturing and life sciences solutions, operating across 30+ sites worldwide. Employees benefit from:
- Strong global regulatory exposure
- Career growth in CMC regulatory affairs
- Diverse and inclusive work environment
- Opportunity to contribute to innovative therapies and medicines
How to Apply
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