BIORCHESTRA is an innovative biotech company focusing on research and development of ribonucleic acid (RNA) based therapeutics. Our goal is to change the therapeutic paradigm from treating the symptoms to modifying the progression of the disease process. As we are making steady progress towards selecting our lead clinical candidate, we are looking for an exceptional candidate as Head of Regulatory Affairs to define our regulatory strategy and to lead our communications and filings with the major national and international regulatory agencies. Based in Daejeon, South Korea, and Cambridge, MA, BIORCHESTRA has identified a novel pathway of neuroinflammation involved in neurodegenerative diseases and has developed proprietary drugs and targeting formulations that allow delivery to the brain through systemic administration.
Head of Regulatory Affairs This position will be based in Cambridge, MA, and will report to the Chief Medical Officer of the Company.
The successful candidate will have senior-level and international experience in Regulatory Affairs and will have led meetings and major filings in the leading regulatory regions The candidate will provide strategic and operational leadership for BIORCHESTRA’s regulatory activities and will ensure regulatory activities are well-prepared, compliant, timely, and successful The candidate will provide guidance to and ensure close collaboration with BIORCHESTRA’s Research, Pharm/Tox, Clinical, and Manufacturing teams, and external partners, to successfully execute on all aspects of the Company’s regulatory commitments. The candidate will build and manage the regulatory team and ensure that its activities are governed by an appropriate Quality System for Regulatory Affairs. The candidate will also monitor global regulatory requirements and trends to ensure the Company adjusts appropriately to changing national and international requirements.