Regulatory Affairs Manager (f/m/d)

Job Description Summary

MiGenTra is seeking a Regulatory Affairs Manager with a track record of successful regulatory approvals and maintenance of regulatory approvals. The Regulatory Affairs Manager will drive and oversee regulatory processes with African and European authorities to gain and maintain marketing authorization for MiGenTra’s biosimilars, cell and gene therapies, and vaccines.

Key Responsibilities

  • Provide guidance on, develop, and implement regulatory strategy by determining submission and approval requirements in targeted regions for new product registrations and post-market changes and by ensuring compliance with current regulations
  • Plan, manage and oversee all aspects of regulatory submissions to gain and maintain marketing authorization in line with country specific regulations
  • Interact with local partners and health authorities to discuss development strategies and to enable approval of regulatory submissions including coordination, preparation and documentation of Scientific Advice meetings
  • Deliver high-quality dossiers and maintain well-organized, auditable regulatory files (including submission content planners, product release matrix)
  • Manage distributors and consultants to ensure registrations are completed on time and maintained
  • Act as primary Regulatory Affairs interface within cross functional project teams and provide guidance on submission processes, standards, and technical specifications before filing, during authority review phase (deficiency letter response) and for maintenance
  • Support regulatory clinical trial reporting (applications, amendments, notifications) and safety reporting in cooperation with Clinical Operations and Pharmacovigilance
  • Monitor changes and updates to applicable legislations and implement procedure revisions when new regulatory requirements become effective
  • Create and implement internal standard processes and documents, compliant to applicable domestic and international regulatory laws/standards and train key personnel on regulatory policies, processes, and SOPs

Qualification & Experiences

  • Degree in pharmacy or life science (Master or PhD [preferred]) or comparable qualification and experience
  • Minimum 10 years’ experience in regulatory affairs (pharmaceutical development)
  • Experience in dossier compilation, submission, approval maintenance and health authority interactions, preferably with EMA- and African-authorities
  • Experience in biosimilar and cell and gene therapy development
  • Proven ability to be flexible and adaptable within a changing dynamic environment and enjoy working in a fast-paced startup environment
  • Goal orientation and ability to comprehend, structure and manage multiple parallel tasks
  • Excellent knowledge of applicable regulatory framework and laws
  • Excellent self-organization skills and team driven spirit
  • Excellent communication skills in German and English (both written and spoken)
  • Proficiency in MS-Office applications

Applicants Contact

Beatrice Wiesner, People & Talent Manager

Beatrice Wiesner
People & Talent Manager

Phone: +49 (0) 30 3229 35 133