Head Of Regulatory Affairs
Company: BIORCHESTRA US INC
Location: Boston
Posted on: May 16, 2022
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Job Description:
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.
The positionHead of Regulatory Affairs This position will be based
in Cambridge, MA, and will report to the Chief Medical Officer of
the Company.
The candidateThe 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.
Key responsibilities
Job Requirements include
BIORCHESTRA is an equal opportunity employer, and all qualified
applicants will receive consideration for employment without regard
to race, color, religion, gender, gender identity, sexual
orientation, national origin, disability status, protected veteran
status, or any other characteristic protected by law.
Contact InformationPlease submit your CV and Resume to
hr@biorchestra.com
Keywords: BIORCHESTRA US INC, Boston , Head Of Regulatory Affairs, Other , Boston, Massachusetts
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