Director, Regulatory Affairs

Lonza • Tampa, FL

10d • Onsite

About The Position

Shape the future of life sciences with Lonza . In this role, you’ll lead regulatory strategies that ensure compliance and accelerate the delivery of life-changing medicines to patients worldwide. What you will get An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. A variety of benefits dependent on role and location. The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.

Requirements

• Bachelor’s degree in chemistry, Biochemistry, or related field required; advanced degree preferred.
• 10+ years of experience in Regulatory Affairs or related pharmaceutical industry roles.
• Expertise in CMC regulatory requirements and submission processes.
• Strong leadership and collaboration skills with ability to influence stakeholders.
• Excellent organizational and communication skills.
• Ability to manage complex projects and meet tight timelines.
• Knowledge of global regulatory frameworks (FDA, EMA, Health Canada).

Responsibilities

• Monitor global and regional regulations to ensure compliance and identify emerging risks.
• Represent Lonza in interactions with Health Authorities and lead regulatory negotiations.
• Develop and implement regulatory strategies that enable successful drug product submissions and support ongoing lifecycle management for our customers.
• Oversee preparation and review of Chemistry, Manufacturing, and Controls (CMC) submissions.
• Collaborate with Quality, Operations, and R&D to align regulatory strategies with business goals.
• Mentor and lead the Regulatory Affairs team, fostering professional growth and excellence.
• Drive continuous improvement initiatives within regulatory processes

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees