Regulatory Affairs Senior Specialist at Lonza - Spain

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

18 Jul, 26

Salary

0.0

Posted On

19 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory affairs, CMC documentation, Dossier authoring, Clinical trial applications, License applications, Product lifecycle management, Veeva Vault, eCTD publishing, Document management systems, Project management, Communication, Stakeholder management, Regulatory compliance, Chemistry, Biology

Industry

Pharmaceutical Manufacturing

Description

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 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 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 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.

Responsibilities

Lead CMC regulatory dossier authoring for clinical and commercial programs while ensuring compliance and accuracy. Manage regulatory workflows and document systems to coordinate successful submission outcomes across the global network.