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Director / Sr Director - Regulatory Affairs at Kanyos Bio
Cambridge, MA, US

Responsibilities

Reporting to the Chief Medical Officer, you will be responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, executing submissions, serving as the regulatory lead on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.

Key Duties

Act as liaison between Regulatory Affairs and other functional areas including CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to governmental regulatory agencies.

Provide regulatory leadership and guidance to project teams, leadership for the development of global regulatory documents requirements

Integrate global regulatory understanding and responsibilities in developing strategy

Provide regulatory expertise and support nonclinical and clinical areas for investigational products

Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts.

Identify and assess regulatory risks for assigned projects or programs

Prepare and deliver effective presentations for external and internal audiences

Participate and contribute in Health Authority meetings

Qualifications

Minimum M.S. degree in life/health/technical sciences required

Minimum of 5 years’ experience in a biotech and/or pharmaceutical environment, including 4-5 years in Regulatory Affairs

Knowledge of global regulatory requirements

Experience with IND preparation and submission

Experience in immunology preferred

Must be a team player that can handle multiple tasks simultaneously in a fast-paced company

Demonstrate excellent communication skills

Ability to represent the function in project teams

Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload

Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff

Experience in interfacing with relevant regulatory authorities

Experience in interpretation of regulations, guidelines, policy statements, etc.