Lonza is recruiting a Regulatory Affairs Specialist for its Global Capability Center (GCC) in Hyderabad. This is a full-time, hybrid opportunity for experienced regulatory affairs professionals with expertise in CMC regulatory writing, global submissions, clinical trial applications and product lifecycle management.
The Lonza Regulatory Affairs Specialist job in Hyderabad involves preparing CMC regulatory dossiers for complex life-sciences products, including bioconjugates, microbial products, cell and gene therapies, vaccines and biologicals.
Professionals with a degree in Chemistry, Biology or a related Life Sciences discipline and 6+ years of regulatory industry experience can review the eligibility requirements and apply before the closing date.
Lonza Regulatory Affairs Job Overview
| Particular | Details |
|---|---|
| Company | Lonza |
| Position | Regulatory Affairs Specialist |
| Function | Regulatory Affairs – CMC |
| Qualification | Chemistry, Biology or related Life Sciences degree |
| Experience | 6+ Years |
| Location | Hyderabad, India |
| Work Model | Hybrid |
| Employment Type | Full-Time |
| Requisition ID | R78619 |
| Application Deadline | 5 October 2026 |
| Relocation Assistance | Available for eligible candidates and families |
Key Responsibilities
As a Regulatory Affairs Specialist at Lonza, the selected professional will support site- and customer-related CMC regulatory activities for global submissions.
Key responsibilities include:
- Support regulatory dossier activities associated with clinical trial applications.
- Write high-quality CMC regulatory dossiers using relevant source documentation.
- Prepare CMC content for bioconjugates, microbial products, cell and gene therapies, vaccines or biological products.
- Ensure regulatory documentation is accurate, complete and compliant with applicable requirements.
- Support product lifecycle management activities.
- Collaborate with Lonza’s network of Regulatory Affairs teams.
- Coordinate regulatory submission activities to support successful submission outcomes.
- Work across multiple projects, priorities and regulatory timelines.
Qualification and Experience
Candidates applying for the Lonza Regulatory Affairs Specialist position should have:
- A degree in Chemistry, Biology or a related Life Sciences discipline.
- 6+ years of experience within the regulatory industry.
- Strong understanding of global regulatory requirements.
- Strong knowledge of CMC documentation for clinical and commercial submissions.
- Experience working with regulatory dossiers and submission documentation.
The job description does not specify B.Pharm, M.Pharm or Pharm.D as named qualifications. Candidates from pharmaceutical backgrounds should therefore verify whether their degree is considered a related Life Sciences discipline by Lonza before applying.
Required Regulatory Affairs Skills
Lonza is specifically looking for candidates with knowledge or experience in:
- CMC regulatory writing
- Global regulatory requirements
- Clinical and commercial submissions
- Clinical Trial Applications
- Regulatory dossier preparation
- Product lifecycle management
- Veeva Vault
- eCTD publishing
- Document management systems
- Project management
- Regulatory submission coordination
- Stakeholder management
- Business-fluent English
Candidates should also demonstrate a collaborative, proactive and solution-oriented approach with strong accountability and ownership.
Why Join Lonza?
Lonza highlights several benefits of working within its global life-sciences organization, including:
- Agile career opportunities and a dynamic working culture
- Inclusive and ethical workplace
- Performance-focused compensation programs
- Collaboration with global cross-functional teams
- Continuous learning and professional development
- Exposure to global life-sciences and regulatory activities
- Relocation assistance for eligible candidates and their families, where required
Specific compensation, relocation eligibility and employee benefits are subject to Lonza’s applicable employment policies.
Salary
The supplied Lonza job description does not disclose a salary range.
For structured-data purposes, a broad estimated market range for an experienced Regulatory Affairs/CMC specialist in Hyderabad could be approximately ₹12,00,000–₹22,00,000 per year.
Important: This is an estimated market range and not an officially disclosed Lonza salary. Candidates should refer to their recruitment communication or employment offer for actual compensation.
How to Apply
