Regulatory Affairs Senior Specialist

Location: Hyderabad, India

Join Lonza’s Global Capability Center (GCC) in Hyderabad and play a key role in global regulatory submissions. As a Senior Specialist in Regulatory Affairs (CMC), you will lead dossier authoring and review activities, provide regulatory guidance, and ensure compliance with global regulatory requirements across development 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

• Lead and review preparation of CMC regulatory dossiers using source documents, ensuring accuracy, completeness, and compliance.

• Provide gap assessments, review comments, and strategic input on CMC documents for clinical and commercial submissions.

• Interpret global regulatory requirements (e.g., US, EU, and other regions) to support compliant submissions across development phases.

• Manage regulatory workflows, trackers, and document systems (e.g., Veeva) to ensure timely and controlled submissions.

• Evaluate regulatory impact of changes, deviations, and updates, ensuring alignment with regulatory strategies.

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

• Collaborate with cross-functional teams and customers to provide regulatory guidance and drive successful submission outcomes.

What we are looking for

• Degree in Chemistry, Biology, or related Life Sciences discipline

• 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.

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.