Director, Regulatory Affairs

Director, Regulatory Affairs Location: Tampa, Florida The actual location of this job is in Tampa, FL. Relocation assistance is available for eligible candidates and their families, if needed. 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. What you will do 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 we are looking for 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). About Lonza At Lonza, our people are our greatest strength. With 30 sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.