Website Lonza
A Regulatory Affairs Specialist opening in Hyderabad has gone live at Lonza, the global contract development and manufacturing organization (CDMO). The role sits inside Lonza’s Global Capability Center (GCC) in Hyderabad and focuses on chemistry, manufacturing and controls (CMC) writing for clinical trial applications and product lifecycle support. This is a hybrid position, and Lonza states that relocation assistance is available to eligible candidates and their families.
This page is an independent third-party summary prepared by SciRealityPress Communications. The original posting and the official application form are hosted by Lonza; always confirm final details on the employer’s careers portal.
Job Snapshot
| Detail | Information |
|---|---|
| Job title | Regulatory Affairs Specialist |
| Employer | Lonza |
| Job ID / Reference | R78616 |
| Location | Hyderabad, India (Hybrid) |
| Function | Regulatory Affairs – CMC |
| Experience | 6+ years in the regulatory industry |
| Education | Degree in Chemistry, Biology or a related life sciences discipline |
| Relocation support | Available for eligible candidates and families |
| Salary (BRJF estimate) | Approx. ₹14–22 lakh per annum (see salary section) |
Role Overview
In this position you will support the site-related and customer-related regulatory dossier activities that underpin clinical trial applications. Lonza describes the work as a key contribution to global regulatory submissions, with the specialist responsible for site and customer CMC writing and for supporting products through their lifecycle.
Because Lonza serves customers across biologics, cell and gene therapy, microbial, bioconjugates and vaccines, the dossiers you write will draw on source documents from several development and manufacturing teams. Accuracy, completeness and compliance are the core expectations, and the writing must stand up to scrutiny from health authorities.
Regulatory Affairs Specialist Hyderabad: Key Responsibilities
- Support site-related and customer-related regulatory dossier activities for clinical trial applications.
- Write CMC regulatory dossiers for bioconjugates, microbial products, cell and gene therapy, vaccines or biologicals, working from source documents and ensuring accuracy, completeness and compliance.
- Support product lifecycle management activities, including post-submission updates.
- Collaborate with Lonza’s network of regulatory teams to coordinate submissions and achieve successful submission outcomes.
Also Check: Product Manager – Sanofi, Taipei
Qualifications and Skills Required
Required
- Degree in Chemistry, Biology or a related life sciences discipline.
- 6+ years of experience in a regulatory industry.
- Strong knowledge of global regulatory requirements and CMC documentation for clinical and commercial submissions.
- Hands-on experience with Veeva Vault, eCTD publishing and document management systems.
- Strong project management skills, with the ability to manage multiple priorities and timelines.
- Excellent communication skills, business fluency in English and the ability to influence stakeholders.
- A collaborative, proactive and solution-oriented mindset with strong accountability and ownership.
To apply for this job please visit www.lonza.com.