Senior Manager Regulatory Affairs (gn)

For a midsize, fast-growing biopharmaceutical client in Munich, we are currently looking for a Senior Senior Manager Regulatory Affairs (gn).

 

Client:

  • Fast-growing, midsize pharmaceutical company specialized in oncology
  • Recent and upcoming launches
  • Very pleasant working atmosphere and international team

 

Your advantages:

  • High degree of responsibility and the opportunity to shape your environment though small teams
  • Excellent career development opportunities
  • Complex pipeline and global submissions

 

Position:

  • Develop and implement global regulatory strategies for complex theragnostic radiopharmaceutical products, including proactive identification of regulatory risks / options and mitigation strategies
  • Coordinate with the cross functional teams to fulfill regulatory submissions by assembling, drafting, editing and reviewing
  • Collaborate with external contractors and consultants in the execution of clinical regulatory activities
  • Write and/or review of regulatory documents required for filing of NDA/MAAs and IND/CTAs, including but not limited to Modules 2.4 – 2.7, Product Information, responses to the Health Authority questions, clinical study protocols and reports, investigator’s brochures, case report forms, informed consent forms and other relevant documents
  • Prepare and/or review briefing documents for Health Authority meetings, Orphan Designations Applications and Paediatric Investigation Plans
  • Contribute to regulatory due diligence of the preclinical and early clinical data in support of early development projects
  • Providing regulatory intelligence to stakeholders by reviewing and evaluating regulations, guidelines, procedures etc.
  • Support development of Target Product Profile for assigned development projects
  • Liaising closely with the Health Authorities and ensuring the optimum relationship between the regulatory authorities and the Company
  • Monitor changes in the regulatory environments and advise on company adaptive responses
  • Supporting pricing and reimbursement activities

Für nähere Informationen kontaktieren Sie bitte: / For more information please contact:

Christian Rommerskirchen
+49 0)89 212 65 333
rommerskirchen@conqure.de

Kontakt!