Clinical Regulatory Affairs Strategist

Contact name: Tom Borchert

Contact email: tom.borchert@medella.life
Job ref: 161
Published: over 3 years ago

Senior Strategist Clinical Regulatory Affairs (f/m/d)

Munich, Bavaria

 

My client is developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing a range of cancers such as neuroendocrine cancers or bone metastases. Their main objectives are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology.

 

Your main Responsibilities will include:

 

  • Develop and implement global regulatory strategies for complex theragnostic radiopharmaceutical products, including proactive identification of regulatory risks / options and mitigation strategies
  • 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
  • Support development of Target Product Profile for assigned development projects
  • Monitor changes in the regulatory environments and advise on company adaptive responses

 

The ideal candidate would have:

 

  • Successfully completed degree in Live Sciences (for example in Chemistry, Biology, Pharmacy or Medicine)
  • Minimum 7 years of regulatory and drug/biologic development experience, ideally in oncology indication; experience with diagnostic radiopharmaceuticals would be an asset
  • Experience in the preparation of regulatory dossiers and submissions to EMA, FDA or other major regulatory authorities Experience in medical writing
  • Proven success in global drug regulatory submissions Leading the regulatory activities from early development to commercial launch
  • Ability to work in a hierarchically flat, matrix environment Good preclinical and clinical data interpretation/data analysis skills
  • Good management, interpersonal, communication, negotiation and problem-solving skills
  • Fluent in English, both written and spoken