Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together.
Post : Regulatory Affairs Specialist
Job Description
• 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.
Candidate Profile
• Degree in Chemistry, Biology, or related Life Sciences discipline with 6+ years of experience in 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 strong accountability and ownership.
Additional Information
Experience : 6+ years
Qualification : Degree in Chemistry, Biology, or related Life Sciences
Location : Hyderabad, India
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th September 2026
Regulatory Affairs Specialist : Apply Online
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