Job Summary

Regulatory Affairs Specialist

Location: Hyderabad, India (Hybrid).

Relocation assistance is available for eligible candidates and their families, if needed.

Join Lonza s Global Capability Center (GCC) in Hyderabad and play a key role in global regulatory submissions. As a Specialist in Regulatory Affairs (CMC), you will be responsible for site and customer CMC writing actvities for clinical trial application and product lifecycle support.

What you will get
An agile career and agile working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Opportunities to collaborate with global cross-functional teams.
Ongoing learning and professional development prospects.
Our full list of global benefits can be found here.

What you will do
Support the site and customer related regulatory dossier activities for clinical trial applications.
Write CMC regulatory dossiers for Drug Substance filing (small and Large API Molecules) using source documents, ensuring accuracy, completeness, and compliance.
Support product lifecycle management activities




Collaborate with Lonza network Regulatory teams to co-ordinate the regulatory submissions to achieve successful submission outcomes.

What we are looking for
Degree in Chemistry, Biology, or related Life Sciences discipline with 6+ years of experience in highly regulated environment.
Strong knowledge of global regulatory requirements and CMC documentation (clinical and commercial submissions).
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 with business fluency in English and ability to influence stakeholders.
Collaborative, proactive, and solution-oriented mindset with robust accountability and ownership.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change.

Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Regulatory Affairs Specialist Hyderabad
🏢 Lonza
📍 Hyderabad