Director, Regulatory Affairs
Job Summary and Essential Functions:
Summary:
This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global
regulations governing pharmaceutical drug development to all aspects of Cara Therapeutics’
quality, preclinical and clinical drug development programs, policies, and procedures, so that
Development teams are able to meet all objectives within specified timelines and so that the
necessary state of compliance is maintained relative to all regulatory commitments/requirements.
Responsibilities:
• Develop regulatory strategies for assigned programs in collaboration with Cara Therapeutics’
Regulatory senior management and by analysis of guidance’s and assessment of drug developed
for similar indication to obtain approval of activities in support of Cara Therapeutics’
development and marketing objectives within specified timelines
• Liaison responsible for communication with FDA and other health authorities for assigned
programs
• Manage/lead regulatory activities associated with Cara Therapeutics assigned drug
development programs.
• Management of the planning, preparation and submission of licensing applications
(NDA/MAA).
• Continually monitor newly published FDA guidelines and international guidance documents in
the context of new and ongoing development programs. Provide training on applicable
requirements for scientific staff as required.
• Manage and mentor direct reports and/or junior staff members.
Experience and Required Skills:
Requirements:
• Requires advanced degree (Ph.D., Pharm.D.) in a science related discipline or relevant
experience demonstrating scientific competence at a similar level
• A minimum of 10 years of pharmaceutical industry experience, at least 5 of which should
include regulatory experience.
• Research laboratory, process development or manufacturing experience with biotechnology
products highly desirable.
• Must possess excellent written and verbal communication skills