Regulatory Affairs Senior Specialist

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

• 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.