Senior Manager Regulatory Affairs Lead(m/w/x)

In this role, you will lead global regulatory efforts for biosimilars, guiding submission strategies and ensuring compliance. Your day-to-day responsibilities will involve collaborating with teams, managing interactions with health authorities, and mentoring junior staff.

Anforderungen

• •Degree in life science or related disciplines
• •At least 6-8 years in international regulatory
• •Experience in managing international or regional regulatory submissions, normally a full global submission (new product application), preferably US BLA or EU MAA
• •Experience in working in development project teams
• •Experience in leading regulatory agency interactions including management of the associated documentation and rehearsals
• •Experience in preparation and coordination of regulatory strategy plan
• •Experience in biological development
• •Experience in CTA requirements
• •Capability to manage a number and range of projects throughout development
• •Excellent written and spoken communication skills
• •Excellent interpersonal skills
• •Understanding of Regulatory Affairs contribution to Pharma business
• •Excellent organizational skills, work independently, self-motivated and proactive
• •Attention to details, without losing the overall picture
• •Ability to think strategically
• •Ability to lead regulatory sub team and work in teams
• •Autonomous, goal-oriented and pragmatic
• •Strong customer-orientation and strong communication skills
• •Fluent command of spoken and written English, additional language skills welcome