Global Regulatory Affairs Strategist (m/f/d)

The Global Regulatory Affairs Strategist (m/f/d) is responsible for the preparation and execution of global regulatory strategies for the assigned projects.

What awaits you:

• Ensure the development and execution of regulatory strategy(ies) for assigned projects across all stages of development and in line with the Global Development Plan, including but not limited Clinical Trial Applications, Marketing Authorisation Applications, Scientific Advice, Applications for Orphan Drug Designations, Pediatric plans, Accelerated Pathway Designations.
• Ensure compliance with both internal processes and policies and with applicable regulatory requirements.
• Provide strategic regulatory input for all development stages of the assigned projects, including study design and geographical placement, development, market access and marketing strategy.
  
• Represent Regulatory Affairs in Global Project Teams for assigned projects
  
• Lead regulatory agency interactions, including briefing document preparation, rehearsals and minutes
• Lead regulatory designation procedures, e.g. orphan applications, accelerated pathway designations.
• Review and provide regulatory input to pharmaceutical quality-related documents, safety-related documents and efficacy-related documents, (e.g. IMPD, Investigator’s Brochure, Clinical Study Protocols, Clinical Study Reports and other reports).
• Support of in-licensing and out-licensing activities is nice to have
• Manage the end-to-end regulatory submission processes to approval including management and coordination of the preparation of all regulatory documentation for assigned project

What we look for in you:

• Your have a degree in Life Sciences
• Minimum of 15 year’s experience in Regulatory Affairs, of which at least 10 years’ regulatory development in oncology and/or hematology.
• Extensive experience as global regulatory lead in global development projects in hematology and/or oncology/immuno-oncology in at least two ICH regions
• Extensive knowledge in preparation of global regulatory strategies for New Chemical Entities (NCEs) and New Biological Entities (NBEs), ideally ADCs.
• Extensive experience in leading regulatory agency interactions and preparation of documentation to support interactions in at least two ICH regions
• Solid experience in leading a full submission/or large variation/supplement in at least one ICH region through to authorization would be nice to have
• Extensive knowledge in Clinical Trial Applications (CTA) requirements worldwide, including initial IND applications
• Proficient experience of accelerated pathway designation applications (e.g. FT, BTD, PRIME, PIM, EAMS) and designations (e.g. ODD)
• Solid knowledge of pediatric requirements, ideally experience with PIP/PSP procedures would be nice to have
• Experience with working on early development projects (FIH) in at least two ICH regions.
• Asia development experience is a plus, e.g. China and experience in co-development projects would be nice to have
• In-depth knowledge of GCP, ICH guidelines, and other relevant regulatory requirements
• Strong leadership and communication skills, with the ability to collaborate effectively across diverse teams and cultures

What we offer:

• Flexible working hours with compensation options and the opportunity to work remotely so that your job fits in with your life
• Mentoring program: In addition to comprehensive onboarding, you will receive a buddy who will show you everything so that you feel at home quickly
  
• Prospects for your personal and professional development: Benefit from our training program so that you can take your qualifications to a new level
  
• We support you and your family through our “FamPlus” Employee Assistance Program, e.g. in organizing childcare or caring for relatives
  
• We offer you a wide range of social benefits: Company pension scheme with employer subsidy, pension benefits as part of company health insurance and job bike
  
• Would you like to improve your fitness? No problem, then join our weekly sports club
  
• You can use our free charging stations for your electric car
  
• Happy coffee break, weekly fruit day and regular great company events await you
  

Would you like to work with us today on the medicine of tomorrow for the benefit of patients? Then become part of our team!