Regulatory Affairs Senior 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 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 professional development opportunities.
- Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.
What you will do
- Support the site and customer related regulatory dossier activities for clinical trial and license 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.
- 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 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.
Skills Required
- Degree in Chemistry, Biology, or related Life Sciences discipline
- 8+ years experience in small molecules Regulatory Affairs
- Strong knowledge of global regulatory requirements and CMC documentation for clinical and commercial submissions
- Experience with Veeva Vault
- Experience with eCTD publishing
- Experience with document management systems
- Strong project management skills with ability to manage multiple priorities and timelines
- Excellent communication skills with business fluency in English and ability to influence stakeholders
- Collaborative, proactive, solution-oriented mindset with strong accountability and ownership
What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
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