Regulatory Affairs Senior Specialist
Lonza View all jobs
- Hyderabad, Telangana
- Permanent
- Full-time
- 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:
- Support the site and customer related regulatory dossier activities for clinical trial 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.
- 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.