Regulatory Affairs Sr Specialist

Job Summary

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.

Location: Hyderabad, India (Hybrid). Relocation assistance is available for eligible candidates and their families, if needed.

What you will do

• Support the site and customer related regulatory dossier activities for clinical trial and license applications.
• Write CMC regulatory dossiers for Bioconjugates, Microbial, Cell Gene Therapy, Vaccine or Biologicals using source documents, ensuring accuracy, completeness, and compliance.
• Support product lifecycle management activities.
• Manage regulatory workflows, trackers, and document systems (eg, 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 a high regulatory environment.
• 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.