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 across development and commercial programs for large and small molecule products.
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 career development opportunities.
What you will do
- 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.
- Manage regulatory workflows, trackers, and document systems (e.g., Veeva) to ensure timely and controlled submissions.
- 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 8+ years of experience in small molecules - Regulatory Affairs
- 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