Apply on Employer Site

Lonza · 10 hours ago

Director, Regulatory Affairs

Tampa, FL

Full-time

Onsite

Director/Executive

10+ years exp

Lonza is a leader in life sciences, and they are seeking a Director of Regulatory Affairs to lead regulatory strategies that ensure compliance and accelerate the delivery of life-changing medicines. The role involves monitoring regulations, representing the company in negotiations, and overseeing regulatory submissions while collaborating with various teams.

BiotechnologyLife SciencePharmaceutical

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

Qualification

Regulatory AffairsCMC submissionsGlobal regulatory frameworksLeadership skillsProject managementCommunication skillsCollaboration skillsOrganizational skills