Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
Not Mentioned
Description
- 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
Qualifications
Highest qualification: University
- 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.