Regulatory Affairs Specialist

Location: Hyderabad, India

Join Lonza’s Global Capability Center (GCC) in Hyderabad and support global regulatory submissions. As a Regulatory Affairs Specialist, you will contribute to CMC dossier authoring, ensuring accuracy, compliance, and timely delivery of regulatory documentation to support clinical and commercial programs.

What you will get

• An agile career and dynamic 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 opportunities.

• Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.

What you will do

• Support preparation, editing, and maintenance of CMC dossiers using source documents and standardized templates.

• Author and review CMC sections for clinical trial and marketing submissions in alignment with regulatory strategies.

• Manage document workflows and trackers using systems such as Veeva to ensure accuracy and timely submissions.

• Perform peer reviews and periodic verification to ensure alignment between customer dossiers and source documents.

• Assess regulatory impact of changes, deviations, and updates to ensure compliance with submission requirements.

• Support site-related regulatory activities including Master File updates, product registrations, and regulatory reporting (e.g., CARES/USFDA).

• Collaborate with internal and external stakeholders to provide regulatory guidance and ensure compliant, on-time delivery.

What we are looking for

• Degree in Chemistry, Biology, Biotechnology, Pharmaceutical Science, or related discipline

• Understanding of pharmaceutical development and manufacturing processes (Drug Substance/Drug Product, sterile/non-sterile, analytical).

• Experience with document management systems (e.g., Veeva) and proficiency in Microsoft Office tools.

• Strong attention to detail with good project planning and prioritization skills.

• Effective written and verbal communication skills with business fluency in English.

• Collaborative, solution-oriented mindset with the ability to work across functions, technologies, and regions.

About Lonza

At 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. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.